Data / Medical devices / Blood/Plasma Collection Device For Dna Testing
Blood/Plasma Collection Device For Dna Testing (PJE): 8 FDA-registered makers in 6 countries
8 establishments in 6 countries are registered with the FDA to make Blood/Plasma Collection Device For Dna Testing (product code PJE, Class 2, 21 CFR 862.1675). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on June 21, 2023, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PJE
- Device class
- 2
- Regulation
- 862.1675
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Brazil | 1 |
| Austria | 1 |
| Switzerland | 1 |
| Germany | 1 |
| United Kingdom | 1 |
Makers of Blood/Plasma Collection Device For Dna Testing
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Greiner Bio One Brasil Produtos Medicos Hospitalar | AMERICANA Sao Paulo, Brazil | Manufacturer | 3 | April 15, 2005 | 0 | 0 | 0 | api.fda.gov |
| Greiner Bio-One GMBH | KREMSMUENSTER Oberosterreich, Austria | Manufacturer, Specification developer | 3 | April 15, 2005 | 0 | 0 | 0 | api.fda.gov |
| Greiner Bio-One North America, Inc. | Monroe, NC, United States | Manufacturer | 3 | April 15, 2005 | 0 | 0 | 0 | api.fda.gov |
| Becton Dickinson | Franklin Lakes, NJ, United States | Specification developer | 1 | February 24, 1998 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Broken Bow, NE, United States | Manufacturer | 1 | February 24, 1998 | 0 | 0 | 0 | api.fda.gov |
| Preanalytix GMBH | HOMBRECHTIKON Zurich, Switzerland | Specification developer | 1 | June 21, 2023 | 0 | 0 | 0 | api.fda.gov |
| Sarstedt AG & Co. KG | NUMBRECHT North Rhine-Westphalia, Germany | Manufacturer | 1 | September 12, 2003 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson & Company (BD) | Plymouth Devon, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 21, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.