NeuMoDx™
Extraction Plate
INSTRUCTIONS FOR USE
100200
NeuMoDx Molecular, Inc.
CONFIDENTIAL
P/N 40600098_Rev D
October 2018
Pg. 3 of 4
For US Distribution Only
4.
Erroneous test results could occur from improper specimen collection, handling, storage, technical error or sample mix-up. In addition, false
negative results could occur because the number of organisms in the specimen is below the analytical sensitivity of the test.
5.
Use of this reagent is limited to personnel trained on the use of the NeuMoDx System.
6.
Good laboratory practices, including wearing gloves while loading all reagents into the system and changing gloves during specimen
preparation is critical to reduce chance of contamination.
REFERENCES
1.
Centers for Disease Control and Prevention. Biosafety in Microbiological and Biomedical Laboratories, 5
th
edition. HHS Publication No. (CDC)
21-1112, Revised December 2009
2.
Clinical And Laboratory Standards Institute (CLSI). Protection of Laboratory Workers From Occupationally Acquired Infections; Approved
Guideline
–
Fourth Edition. CLSI document M29-A4; May 2014
TRADEMARKS
NeuMoDx™
is a trademark of NeuMoDx Molecular, Inc.
TaqMan® is a registered trademark of Roche Molecular Systems, Inc.