Recognized standard
C59-A
FDA recognition 7-175 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-175 |
|---|---|
| Designation | C59-A |
| Title | Apoplipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jul 9, 2014 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | This guideline describes the characterization and preparation of immunogens, antibodies, samples, and methods, and provides guidance for immunochemical testing of apolipoproteins. |
At a glance
- 1–9 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: