Recognized standard
H47-A2
FDA recognition 7-205 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-205 |
|---|---|
| Designation | H47-A2 |
| Title | One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline - Second Edition. |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | May 5, 2010 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard describes the principles and procedures necessary for the routine performance of the PT and APTT by conventional techniques using citrated plasma. Each of the two tests measures the time for a fibrin clot to develop in test plasma after activation. The chemical reactions are complex… |
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: