Blood/Plasma Collection Device For Dna Testing
FDA product code PJE · Class II (moderate risk) · 21 CFR 862.1675 · Clinical Chemistry
A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing.
8510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231469 | PAXgene® Blood DNA TubePJE · Special | Preanalytix GmbH | 06/21/2023SE |
| K142821 | PAXgene Blood DNA TubePJE · Traditional | Preanalytix GmbH | 09/09/2015SE |
| K042927 | Vacuette Edta K3 Evacuated Blood Collection TubesPJE · Traditional | Greiner Bio-One Vacuette North America | 04/15/2005SE |
| K031359 | S-Monovette Edta K2-GELPJE · Traditional | Sarstedt, Inc. | 09/12/2003SE |
| K014104 | Vacuette Edta K2 TubesPJE · Traditional | Greiner Vacuette North America, Inc. | 02/01/2002SE |
| K012043 | Vacuette Edta K2 Gel TubesPJE · Traditional | Greiner Vacuette North America, Inc. | 09/24/2001SE |
| K010328 | Multiple (Izon DNA Blood Collection Kit)PJE · Traditional | Izon Business Products, Inc. | 04/09/2001SE |
| K972075 | Vacutainer Brand PPT Plasma Preparation TubePJE · Traditional | Becton Dickinson Vacutainer Systems | 02/24/1998SE |