| CLSI GP41 7th Edition Collection of Diagnostic Venous Blood Specimens |
| Recognition Number | InVitro Diagnostics |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 7-277 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | InVitro Diagnostics |
| FDA Tech | Yvonne Doswell FDA/OMPT/CDRH/OIR/DIHD/HEMB/ 240-402-5025 yvonne.doswell@fda.hhs.gov |
The standard provides processes and procedures that are appropriate for venous blood specimen collection for the clinical laboratory testing.
This standard establishes criteria for suitable venous blood specimen collection for medical laboratory testing. These procedures are intended as an appropriate model for adoption by all health care providers responsible for blood specimen collection in outpatient and inpatient settings.
| Regulation Number | Device Name | Device Class | Product Code |
| §864.7925 | Activated Partial Thromboplastin | Class 2 | GFO |
| §864.7750 | Test, Time, Prothrombin | Class 2 | GJS |
| §864.5220 | Counter, Differential Cell | Class 2 | GKZ |
| §862.1675 | Tubes, Vacuum Sample, With Anticoagulant | Class 2 | GIM |
| §862.1675 | Tubes, Vials, Systems, Serum Separators, Blood Collection | Class 2 | JKA |
| CLSI GP39-A6 Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard - Sixth Edition. |