Siemens ADVIA 2120, Operator'S Manual, Page: 359 / 477

9-18 Regulatory Information
CLSI Document M29-A3 and Siemens Method Topics Cross Reference
CLSI Approved Guideline M29-A3 Siemens Method
Topics
5.1.2 Title
5.1.2.1 Title
5.1.2.2 Type of Specimen Intended Use
5.1.2.3 Method or instrumentation
in subtitle Intended Use
5.1.3 Principle
5.1.3.1 Type of reaction(s) involved Principles of the
Procedure
5.1.3.2 Clinical reasons for
performing the test Intended Use
5.1.4 Specimen
5.1.4.1 State the conditions for
patient preparation Sample Handling /
Limitations of the
Procedure
5.1.4.2 Type of specimen Intended Use / Sample
Handling
5.1.4.3 Special handling conditions Sample Handling
5.1.5 Reagents
5.1.5.1 List reagents, supplies, and
equipment Reagents
5.1.5.2 Directions for preparation Reagents
5.1.5.3 Parameters used to determine
acceptable reagent
performance Storage and Stability /
Quality Control
5.1.5.4 Storage requirements Storage and Stability
5.1.6 Calibration
5.1.6.1 Standard preparation Not applicable
5.1.6.2 Calibration procedure Calibration
5.1.7 Quality Control
5.1.7.1 Identify control materials to
be used Quality Control