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997-0005

NucleoCounter® NC-202™

Document Compilation

V 1.0

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Содержание NucleoCounter NC-202

Страница 1: ...997 0005 NucleoCounter NC 202 Document Compilation V 1 0 Page 1 of 127...

Страница 2: ...ssettes 17 Statement ChemoMetec Cassette Conformity Statement 18 Certificate Example 992 3102 Certificate of Analysis Via2 Cassette 19 880 0030 76A QA Measures in the Production of ChemoMetec Cassette...

Страница 3: ...25 Tech Note NC 202 PQ check list 53 994 2026_App Note 2026 Count Viability Via2 Cassette 57 994 2028 App Note 2028 Lysis Count Via2 Cassette 60 User s Guides and White Papers 991 2020 NucleoCounter N...

Страница 4: ...lication area In pursuit of this we are dedicated to the following points Commitment to meeting customer requirements and to continually strive to improve the services offered by the company Achieving...

Страница 5: ...mber into a single workflow Together the NucleoCounter NC 202 and Via2 Cassette generate data with low inter and intra operator variation The NucleoCounter NC 202 can count all mammalian cell types in...

Страница 6: ...rrelation with an R2 of 0 918 Figure 1 NucleoCounter NC 202 total cell count correlates with manual counting The graph presents data from 15 different cell types with 166 measurements using three Nucl...

Страница 7: ...follow the Poisson probability distribution where measurements of discrete events will deviate with the square root of the number of events counted In addition variation in sample collection and proce...

Страница 8: ...ta from 15 different cell types with 166 measurements using A three NucleoCounter NC 202 instruments and B manual counting CV indicates coefficient of variation 0 5 10 15 20 25 30 35 40 45 50 55 1 E 0...

Страница 9: ...quire any adjustment by the user Consequently all NucleoCounter NC 202 instruments are inter comparable regardless of production year When normalized total cell counts are compared between three Nucle...

Страница 10: ...Ovary Epithelial like suspension FreeStyle 293 F Human Embryonic Kidney Epithelial suspension HEK293T Human Embryonic Kidney Epithelial adherent HeLa Human Cervix Epithelial adherent HMEC Human Breast...

Страница 11: ...ted The relative precision expressed as Coefficient of Variation CV is therefore To measure the variation of the true count CV is often preferred as it can be expressed as a percentage and allows for...

Страница 12: ...ty One contributor could be the precision of the pipetting volume which is dependent on how well the pipettes have been calibrated Manual cell counting Manual cell counting using a hemocytometer and t...

Страница 13: ...counting highly subjective One operator may include an object that another operator may discard during cell counting For instance different operators may have different perceptions of what exactly def...

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Страница 17: ...assette carries a dot code that indicates the exact volume of its counting chamber This dot code is read by the NucleoCounter instrument and is used by the software to calculate the cell concentration...

Страница 18: ...thin the Cassette and will not be released during use and the Cassette including the sample can safely be disposed of after use Based on Guidance on requirements for substances in articles Version 4 0...

Страница 19: ...t 3 data Lot mmyy xx Total Cell Count x106 Cells ml Coefficient of Variation Total Cell Count x106 Cells ml Coefficient of Variation Viability This lot has been tested according to the internal ChemoM...

Страница 20: ...al 2 Related Documentation 2 Revision History 2 Product and Service Inputs 3 Key Characteristics Specifications 3 Inspection Points and Monitoring Metrics 3 Entrance Control of Raw Material 3 Producti...

Страница 21: ...A person responsible for releasing the document Related Documentation Document no Document name 880 0017 79 Template for SOP Revision History Revision Date Initials Description 1 15 Jun 2015 LBP New d...

Страница 22: ...ia2 Cassette Document number 992 3101 Inspection Points and Monitoring Metrics Entrance Control of Raw Material When a new lot of molded plastic components arrive samples aretaken The samples are meas...

Страница 23: ...is constant and specific for each instrument The dot code must be correctly placed and readable 100 test checked by a vision system on the assembly line Cassettes that fail any of the inspection steps...

Страница 24: ...d a training log has been created document number 880 0016 77 and 880 0016 94 respectively These documents pertain to training of new employees in the Manufacturing and QC departments Training records...

Страница 25: ...nce control of raw material The new prodution schedule is sent to the production team logistics and QC Production initiated Line 1 Reagent Dispensing Dispensing of reagent and placement of porex in th...

Страница 26: ...ckaging The bags are packaged in boxes of 10 bags The label is checked on every bag Line 3 Bagging a The cassettes are bagged 10 cassettes in each bag b An anti moisture bag is added to the cassette b...

Страница 27: ...ch as DAPI Usage The solution is for research and development purposes only and is not for diagnostic or therapeutic use Storage Store at room temperature Product will precipitate below 15 C Check buf...

Страница 28: ...ia in REACH Annex XIII SECTION 3 Composition information on ingredients 3 2 Mixtures w w Substance name CAS no EC no Index no REACH reg no Classification 5 Orthophosphoric 7664 38 2 231 633 2 015 011...

Страница 29: ...tainer 7 3 Specific end use s See section 1 SECTION 8 Exposure controls Personal protection 8 1 Control parameters Occupational exposure limits EH40 2005 Substance 8 hour TWA 15 min STEL Comments Orth...

Страница 30: ...o Litt CMR No CMR effects Orthophosphoric acid No carcinogenicity nor mutagenicity Cetylpyridinium chloride Miscellaneous No info Various ECHA Litt Information on likely routes of exposure Inhalation...

Страница 31: ...ere skin burns and eye damage H315 Causes skin irritation H318 Causes serious eye damage H319 Causes serious eye irritation H330 Fatal if inhaled H335 May cause respiratory irritation H400 Very toxic...

Страница 32: ...K 3450 Allerod Denmark Support chemometec com www chemometec com Certificate of Product Testing 910 0010 Mmm yyyy Mmm yyyy This lot has been tested according to the internal ChemoMetec quality procedu...

Страница 33: ...procedure please refer to the appropriate application and technical notes and user manual for the NucleoCounter NC 202 instrument and the NC View NC 202 Software NC 202 IQ OQ Kit is for research and...

Страница 34: ...edients 3 2 Mixtures w w Substance name CAS no EC no Index no REACH reg no Classification Note 0 015 Sodium azide 26628 22 8 247 852 1 011 004 00 7 Acute Tox 2 H300 1 Aquatic Acute 1 H400 Aquatic Chro...

Страница 35: ...Personal protection 8 1 Control parameters Occupational exposure limits EH40 2005 with later amendments Substance TWA 8h STEL 15 min Comments Sodium azide 0 1 mg m3 0 3 mg m3 Sk can be absorbed throug...

Страница 36: ...sitization guinea pig OECD 419 ECHA CMR TDLo 2730 mg kg 78W rat continuous Equivocal tumorigenic agent TDLo 177 5 mg kg rat 6 19 days after birth Effects on embryo or foetus No info No info RTECS RTEC...

Страница 37: ...400 Very toxic to aquatic life H410 Very toxic to aquatic life with long lasting effects EUH032 Contact with acids liberates very toxic gas EUH210 Safety data sheet available on request Abbreviations...

Страница 38: ...etec A S Gydevang 43 DK 3450 Allerod Denmark Support chemometec com www chemometec com 0 0 Jan 1900 Certificate of Product Testing 912 2021 NC 202 IQ OQ Kit is part of the NucleoCounter NC 202 system...

Страница 39: ...ntain beads that will be detected in the AO and DAPI channel Both bead types will contribute to the total counts Usage With respect to the description of the detailed PQ procedure please refer to the...

Страница 40: ...edients 3 2 Mixtures w w Substance name CAS no EC no Index no REACH reg no Classification Note 0 015 Sodium azide 26628 22 8 247 852 1 011 004 00 7 Acute Tox 2 H300 1 Aquatic Acute 1 H400 Aquatic Chro...

Страница 41: ...Personal protection 8 1 Control parameters Occupational exposure limits EH40 2005 with later amendments Substance TWA 8h STEL 15 min Comments Sodium azide 0 1 mg m3 0 3 mg m3 Sk can be absorbed throug...

Страница 42: ...sitization guinea pig OECD 419 ECHA CMR TDLo 2730 mg kg 78W rat continuous Equivocal tumorigenic agent TDLo 177 5 mg kg rat 6 19 days after birth Effects on embryo or foetus No info No info RTECS RTEC...

Страница 43: ...400 Very toxic to aquatic life H410 Very toxic to aquatic life with long lasting effects EUH032 Contact with acids liberates very toxic gas EUH210 Safety data sheet available on request Abbreviations...

Страница 44: ...ent Count x 104 beads mL P N 071 0029 Viability Certificate of Analysis for lot 0 0 Jan 1900 Mmm yyyy 912 2022 Release date Exp Date NC 202 PQ Kit Using the Via2 Cassette and Count Viability Assay on...

Страница 45: ...oards The IQ test verifies correct installation of the instrument The OQ test performs a series of functional and quantitative measurements to verify correct operation of all these units The Zero Coun...

Страница 46: ...in the message box 4 Next shake the NC 202 OQ Beads Fluorescent Beads vigorously to bring the beads into solution Then load the Via2 Cassette with the bead solution 5 A message box will prompt you to...

Страница 47: ...ment and might depend on the type of cells being analyzed Refer to the NucleoCounter NC 202 user guide for instructions and limitations Liability disclaimer This application note is for RESEARCH PURPO...

Страница 48: ...ualification Protocol N A Purpose To verify that the NC 202 Instrument is installed correctly Select the NC 202 IQ OQ protocol press Run select IQ and follow on screen instructions and instructions fr...

Страница 49: ...xecution of the Operation Qualification OQ Protocol N A OK Yes Fail No If the above category is Fail No checked please contact the person responsible within your organization or your local ChemoMetec...

Страница 50: ...Kit Each of the three solutions contains a mixture of two bead types The first type constituting approximately 95 will emit green light in the NC 202 instrument mimicking Acridine Orange AO positive...

Страница 51: ...of the obtained results to validate precision of the NucleoCounter NC 202 It is not recommended to use one NC 202 PQ Kit for more than one PQ test The volume of the bead suspension in each vial is del...

Страница 52: ...r to the NucleoCounter NC 202 user guide for instructions and limitations Liability disclaimer This application note is for RESEARCH PURPOSES ONLY It is not intended for food drug household or cosmeti...

Страница 53: ...ication Instrument Type NucleoCounter NC 202 Cat no 900 2020 Instrument Serial Number Firmware versions System Controller Piston Software version NC 202 PQ Kit Cat no 912 2022 Expiry Date and Lot numb...

Страница 54: ...before a Via2 cassette is loaded with the bead suspension Carry out an analysis on the NucleoCounter NC 202 instrument and note the results in the table provided below Important Close the bottle and i...

Страница 55: ...elow the accepted maximum value OK Yes Fail No Is the viability within the accepted range OK Yes Fail No Is the CV on the viability below the accepted maximum value OK Yes Fail No Beads High N A Count...

Страница 56: ...es N A OK Yes Fail No b Beads 2 within accepted ranges N A OK Yes Fail No c Beads 3 within accepted ranges N A OK Yes Fail No OBS If any of the points above are Fail No please contact ChemoMetec Suppo...

Страница 57: ...d place the Via2 Cassette in the NucleoCounter NC 202 and press RUN to acquire data Viability and cell concentration data is automatically analyzed and presented Procedure Adherent or semi adherent ce...

Страница 58: ...as described above Viability The percent viability is calculated from Viability Ct Cnv Ct 100 Viability The Percentage of viable cell in the cell sample Ct The total concentration of cells Acridine O...

Страница 59: ...202 user guide For other reagents refer to the safety data sheet from the manufacturer of the reagents and chemicals required for this protocol Wear suitable eye protection and protective clothes and...

Страница 60: ...e dependent cells e g cells growing on micro carriers Introduction Determination of both cell count and viability requires two Via2 Cassettes For measuring the total cell concentration a sample contai...

Страница 61: ...ond Via2 Cassette Cnv The concentration of non viable cells DAPI positive cells in the second Via2 Cassette Procedure Adherent or semi adherent cells are released from the cell culture surface e g by...

Страница 62: ...own by clicking cell overlay right panel Figure 1 All cells should be highlighted while cellular debris should be excluded Note that the Total overlay marks the cells identified in the first Via2 Cass...

Страница 63: ...of cells being analyzed Refer to the NucleoCounter NC 202 user guide for instructions and limitations Liability disclaimer This application note is for RESEARCH PURPOSES ONLY It is not intended for fo...

Страница 64: ...NC 202 Instrument User Guide P N 991 2020 Revision 1 3 March 2020 ChemoMetec A S Gydevang 43 DK 3450 Aller d Denmark Telephone 45 48 13 10 20 Website www chemometec com E mail contact chemometec com P...

Страница 65: ...1 or e mail sales chemometec com Disclaimer Notices The material in this document and referred documents is for information only and is subject to change without notice While reasonable efforts have b...

Страница 66: ...ts for harmonic current emissions EN 61000 3 3 1995 A1 A2 2013 Limitation of voltage changes voltage fluctuations and flicker Standards MD EN 12100 1 2003 Safety of machinery Basic concepts general pr...

Страница 67: ...end of its working life To prevent possible harm to the environment or human health from uncontrolled waste disposal please separate this from other types of wastes and recycle it responsibly to prom...

Страница 68: ...level Low magnification 2 1 and a large sensor area 2 3 facilitate a high volume of analytical samples thereby providing great statistical performance The NucleoCounter NC 202 light sources deliver ho...

Страница 69: ...for connecting the power supply The NucleoCounter NC 202 should only be used with an external power supply purchased from ChemoMetec The detachable DC power supply cable set and the appliance inlet of...

Страница 70: ...tion between the equipment and receiver Connect the equipment to an outlet on a circuit different from the receiver connection Consult the dealer or an experienced radio TV technician for help Caution...

Страница 71: ...Loading the Via2 Cassette cassette 6 2 2 2 Via2 Cassette volume calibration dot code 7 2 2 3 Cassette handling 7 3 NUCLEOCOUNTER NC 202 INSTRUMENT CONTROLS 8 3 1 INTERACTIVE CONTROLS 8 3 2 NUCLEOCOUNT...

Страница 72: ...2 15 7 2 SAMPLE MEDIA 15 7 3 EU STANDARDS 15 8 EQUIPMENT AND ACCESSORIES 17 9 OTHER DOCUMENTATION 17 APPENDIX A DESCRIPTION OF CHANGES FROM LATEST REVISION 18 A 1 NEW 18 A 1 CHANGES 18 A 2 REMOVED 18...

Страница 73: ...If any part of the order was damaged during shipping is missing or fails to operate please contact ChemoMetec immediately 1 1 Installation and Operation Qualification of NucleoCounter NC 202 The Nucl...

Страница 74: ...1 Fluorescence microscope The NucleoCounter NC 202 is a fully automated fluorescent microscope with a 2 1 magnification It is equipped with two light sources and a dual band emission filter Together w...

Страница 75: ...he electromagnetic force is caused by two electromagnetic actuators To ensure consistency during closing and positioning of the focal plane these two electromagnetic actuators are operated with a smal...

Страница 76: ...creates a vacuum that draws approximately 60 l cell sample into the cassette flow system The Via2 Cassette is designed for microcentrifuge tubes and accepts a minimum sample volume of 100 l Figure 2...

Страница 77: ...he NucleoCounter NC 202 instrument and Via2 Cassette 2 2 2 Via2 Cassette volume calibration dot code During Via2 Cassette production the precise depth of the measurement chamber is measured for every...

Страница 78: ...ng the cassette fixture The cassette is placed in the cassette fixture and locked in position by an electromagnet when running a protocol Fixing the cassette during acquisition ensures that the measur...

Страница 79: ...ivered with a region specific power cable to connect the external power supply to the main power supply Figure 4 Rear view of the NucleoCounter NC 202 3 2 1 NC 202 power connection The NucleoCounter N...

Страница 80: ...t Figure 6 USB 3 0 port Launching the NC View software commences a short initialization sequence which includes an instrument communication check and positioning of the piston motor After initializati...

Страница 81: ...con in the NC View software or the RUN button on the instrument can be used to execute the protocol of interest A standard operating procedure for NucleoCounter NC 202 should include the following ste...

Страница 82: ...ample has been loaded into the measurement chamber and reaches the end of the flow channel the piston is stopped 4 3 Protection of the Optical System The lid covering the cassette fixture is designed...

Страница 83: ...and dust free cloth reducing fiber contamination of the cassette fixture 5 1 3 Contamination of the optics Foreign objects attached to the optical component can influence the collected image and may b...

Страница 84: ...NC 202 does not turn on please verify that the power supply is connected to the NucleoCounter NC 202 and a working power outlet If the NucleoCounter NC 202 still does not turn on inspect and or repla...

Страница 85: ...lable Intel Core i7 or i9 processor with at least 2 5 GHz clock rate Minimum Screen resolution 1920 1080 pixels M2 SSD disk with at least 500GB At least 16 GB RAM and 10 GB free disc space Analysis ti...

Страница 86: ...ement control and laboratory use Standards MD EN 12100 1 2003 Safety of machinery Basic concepts general principles for design Part 1 EN 12100 2 2003 Safety of machinery Basic concepts general princip...

Страница 87: ...ntation The table below shows a list of documents relevant for NucleoCounter NC 202 operations These documents can be downloaded from www chemometec com Document Document Type Document number Quick Us...

Страница 88: ...18 Appendix A Description of changes from latest revision This chapter describes changes from latest version of this user guide A 1 New N A A 1 Changes Updated information on Cassette fixture to secti...

Страница 89: ...odstranjevanju ne smete me ati z drugimi gospodarskimi odpadki Slovakia Spr vna likvid cia tohoto v robku Elektrotechnick a elektronick odpad Plat len pre Eur pu Toto ozna enie na v robku alebo v spr...

Страница 90: ...i mesti kartu su kitomis buitin mis atliekomis Kad b t i vengta galimos nekontroliuojamo atliek i metimo alos aplinkai arba moni sveikatai ir siekiant skatinti aplink tausojant antrini aliav panaudoji...

Страница 91: ...s del contrato de compra Este producto no debe eliminarse mezclado con otros residuos comerciales Greece Germany Korrekte Entsorgung dieses Produkts Elektrom ll Nur Europa Anzuwenden in den L ndern de...

Страница 92: ...or stated herein including results obtained from use of NucleoCounter NC 202 or Via2 Cassette shall be construed to imply any warranty or guarantee ChemoMetec and affiliated companies shall not be hel...

Страница 93: ...Software User Guide P N 991 2022 Revision 1 3 January 2020 ChemoMetec A S Gydevang 43 DK 3450 Allerod Denmark Telephone 45 48 13 10 20 Website www chemometec com E mail contact chemometec com Page 93...

Страница 94: ...claimer Notices The material in this document and referred documents is for information only and is subject to change without notice While reasonable efforts have been made in preparation of these doc...

Страница 95: ...TROL SECTION TO ACQUIRE DATA 7 Sample and Dilution Volumes 8 OPERATING THE IMAGE PANEL 9 Configure Result Fields 9 Visual Inspection of Counted Cells 10 FILE LIST IN MAIN WINDOW 11 Tool Bar 11 Data in...

Страница 96: ...the LED indicator on the instrument becomes green the instrument is ready to use Select a protocol in the drop down menu or via the Select Protocol icon Load the Via2 Cassette with a cell sample and...

Страница 97: ...USB key provided 3 Launch the Install NC View X X X X exe the Xs indicate the version number e g 1 0 60 0 exe using administrator permissions WARNING Do NOT open the bin file 4 Follow the on screen in...

Страница 98: ...lation Qualification IQ and Operation Qualification OQ protocols Installation Qualification IQ and Operation Qualification OQ 1 Start NC View up via the NC View icon in the Windows start menu 2 Click...

Страница 99: ...t contains the images the result data and the metadata with file information The file type is displayed as cm Protocol A file containing the settings on how the instrument acquires images performs the...

Страница 100: ...Data The control section on the Main Window is used for acquisition of new data 1 Use the drop down or the Select Protocol icon and select the protocol of interest 2 Load the Via2 Cassette with the c...

Страница 101: ...when calculating the results When selecting a protocol the volumes fields will automatically update with the recommended volumes for the assay The Reload icon will load the recommended volumes If the...

Страница 102: ...a CM file Configure Result Fields On the right side of the image panel three results fields are shown These fields can be configured by right clicking on the results category for example Diameter and...

Страница 103: ...mail contact chemometec com Web www chemometec com FORM 880 0011 79 v 2 10 Visual Inspection of Counted Cells The overlays within a CM file can be used to visually inspect how the cells are counted by...

Страница 104: ...umns o Name CM file name date and run count o Time Timepoint for when the CM file was created o Sample ID User defined sample ID o Tags Tags that have been added to the CM file o Protocol Protocol nam...

Страница 105: ...er than 1 107 cells ml Bubble detected A bubble that significantly affects the results is detected and removed from the analysis Foreign object detected A foreign object that significantly affects the...

Страница 106: ...yzed Protocols are selected via the Protocol Browser or the drop down menu The Protocol Browser is opened from the Main Window with the Protocol Browser icon By selecting a protocol and clicking the A...

Страница 107: ...nput parameters Updates the input fields on the Main Window with the parameters that the selected file was acquired with Copy file s to folder Opens a new window where files can be copied to another d...

Страница 108: ...rs Select all users or a single user to locate the specific CM files of interest Tags Select all tags or a single tag to locate the specific CM files of interest Calendar Select year month and day to...

Страница 109: ...n the file list of the Main Window or in the File Browser 2 Click the PDF report icon to open the print options window 3 The PDF report name is named as the CM file name by default If a single file is...

Страница 110: ...ificate of Product Testing for the instrument can be opened via the About box This is opened by selecting Help in the menu line of the Main Window followed by choosing About Installation Guide Minimum...

Страница 111: ...s for installing third party drivers will appear e g Point Grey camera and other device drivers Installing these drivers is required Uninstall Procedure 1 Right click on NC View in the Windows start m...

Страница 112: ...nitializes as a USB 2 connection Please ensure the following 1 The USB cable supplied by ChemoMetec is used 2 A USB 3 1 port on the computer is used 3 The USB cable is securely connected to the instru...

Страница 113: ...switch or socket wait for 10 seconds and then turn it back on Check the USB connection from the instrument to the computer NucleoCounter NC 202 Abnormal sounds from the instrument Instrument not init...

Страница 114: ...es in NC View via Help Create support files before contacting ChemoMetec Support Using this functionality will create two files SupportFiles zip and CrashDumpFiles zip These files should be referred t...

Страница 115: ...Contents Introduction 2 Scope 2 Background 2 Setting up NC View 3 Create security groups 3 Assign users to predefined User groups 3 Activate Secure Mode 3 User level restrictions 4 File types and dat...

Страница 116: ...NucleoCounter NC 202 and NC View hereafter referred to as customers are responsible for the configuration qualification and validation activities required for their application The NC View data files...

Страница 117: ...application and can disable 21 CFR Part 11 mode breaking the 21 CFR Part 11 compliance Users belonging to the securemodesupv and securemodeuser groups have restricted user rights in NC View The rights...

Страница 118: ...Log User Group Name securemodeadmin or Windows Admin securemodesu pv securemodeuser all others Run application Yes yes yes no Change user from same Windows user login session yes yes yes no Change use...

Страница 119: ...ile format with the cm extension and are named based on date and data recording sequence It is not possible to overwrite image files within the NC View system Image files are stored in the NC View Dat...

Страница 120: ...activated during this action USER NAME This is the Windows user name used to log in to NC View at startup when login is enabled Option Authentication Secure Mode Require at startup If the login option...

Страница 121: ...e Mode Disabled Copying files to destination Prevented Prevented Copying files from destination Allowed Allowed Reading files Allowed Allowed Editing files Prevented Prevented Creating files Prevented...

Страница 122: ...ry Active Directory AD is a Microsoft directory service that among other things are used for authentication of users and computers in a Windows domain network Secure Mode A collection of software func...

Страница 123: ...or from the use of the information contained herein ChemoMetec A S reserves the right to make changes in the product without reservation and without notification to its users ChemoMetec A S assumes n...

Страница 124: ...to identify live and dead cells The NC View software is used for the operation of the NucleoCounter NC 202 Background The NucleoCounter NC 202 acquires data and stores it in a CM file format The NC V...

Страница 125: ...and name of the master protocol e g Large Single Cells Company X 1 1 26 derived from Count Viability 5 Software version NC View 1 1 7 0 Column 2 field is a string The software version used for generat...

Страница 126: ...e separated by 20 Comments Test setup 2019 11 23 13 41 51 Added by userb Column 2 field is a string The Comments added If multiple comments have been added they are separated by 21 Status OK Column 2...

Страница 127: ...d on correct use of the reagents cassettes and the NucleoCounter NC 202 instrument and may depend on the type of cells being analyzed Refer to the NucleoCounter NC 202 user s guide for instructions an...

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