Recognized standard
C37-A
FDA recognition 7-88 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-88 |
|---|---|
| Designation | C37-A |
| Title | Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Mar 8, 2004 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | This guideline details procedures for the manufacture and evaluation of human serum pools for cholesterol measurement. |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: