Recognized standard
M35-A2 (Replaces M35-A)
FDA recognition 7-197 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-197 |
|---|---|
| Designation | M35-A2 (Replaces M35-A) |
| Title | Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second Edition. |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Aug 20, 2012 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | This standard includes the minimum identification criteria that can be used to rapidly identify a limited number of organisms commonly isolated from patient specimens. Although these tests do not rule out an occasional misidentification, those errors may not have important consequences with regard… |
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: