Recognized standard
I/LA28-A2
FDA recognition 7-219 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-219 |
|---|---|
| Designation | I/LA28-A2 |
| Title | Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition. |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Aug 2, 2011 |
| Device classes | Class 2, Class 1, Class 3 |
| Scope (excerpt) | This guideline focuses on validation of immunohistochemistry assays on formalin-fixed, paraffin-embedded pathology material. The audience for this guideline includes the assay developer, the reagent supplier, laboratory histotechnologist who performs the assay, and the laboratory… |
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: