Recognized standard
M48-A 2nd Edition
FDA recognition 7-285 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-285 |
|---|---|
| Designation | M48-A 2nd Edition |
| Title | Laboratory Detection and Identification of Mycobacteria |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 1 |
| Scope (excerpt) | This standard addresses topics related to the laboratory diagnosis of mycobacterial infections including safety and related issues, levels of service and referrals, clinical significance of mycobacteria, acceptable specimen types and their collection, transport and storage, specimen processing… |
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: