Recognized standard
M22-A3 Vol 24 No. 19 Replaces M22-A2 Vol. 16 No. 16
FDA recognition 7-178 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-178 |
|---|---|
| Designation | M22-A3 Vol 24 No. 19 Replaces M22-A2 Vol. 16 No. 16 |
| Title | Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard - Third Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | This standard contains quality assurance procedures for manufacturers and users of prepared, ready-to-use microbiological culture media. |
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: