Recognized standard
M40-A2 (Reaffirmed: September 2019)
FDA recognition 7-250 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-250 |
|---|---|
| Designation | M40-A2 (Reaffirmed: September 2019) |
| Title | Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition. |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jan 27, 2015 |
| Device classes | Class 1 |
| Scope (excerpt) | This document provides criteria to assist manufacturers and end users of transport devices in providing and selecting dependable products for the transport of microbiological clinical specimens. |
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: