Home › Shenzhen Dakewe Bio-engineering Co., Ltd › Dakewe
Dakewe
Shenzhen Dakewe Bio-engineering Co., Ltd · Model ITMN · UDI-DI 06973471960552
QBD
Prescription
1
510(k) clearances
0
Adverse events
7
Recalls
23
Facilities
Description
3 mL of Inactivated Transport Medium in screw-cap tube, with nasopharyngeal swabs. 50 tests per package.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-08-09 | DEWEI MEDICAL EQUIPMENT CO LTD | Products were distributed in the United States without FDA authorization or clearance. |
| 2022-01-10 | BASE 10 GENETICS INC | The product does not have 510(k) clearance. |
| 2021-06-10 | Mercedes Medical, Inc. | No 510(k) clearance |
| 2021-06-10 | Mercedes Medical, Inc. | No 510(k) clearance |
| 2021-03-11 | Krishe Inc | Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing |
| 2021-03-11 | Krishe Inc | Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing |
| 2020-06-03 | LONGHORN VACCINES AND DIAGNOSTIC | The tubes may have been delivered to some users without labels. Users may not be able to identify the tubes without these labels. If samples stored or transported in tubes are test |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.