Recognized standard
I/LA23-A (Replaces I/LA23-P)
FDA recognition 7-113 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-113 |
|---|---|
| Designation | I/LA23-A (Replaces I/LA23-P) |
| Title | Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Nov 8, 2005 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | This guideline addresses components for harmonizing and assessing the quality of immunoassay systems for several commonly used dose-response indicator categories, e.g., radioisotopes, enzymes, fluorescence, luminescence, reagents, and experimental components criteria essential to characterizing an… |
At a glance
- 10–99 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: