Hemoglobin Variants System 250-0003
Hemoglobin Variants System 250-0003 (2500003) is a Class II device made by Bio-Rad Laboratories, cleared under FDA 510(k) K171664 on 13 Sep 2017 and listed in FDA GUDID since 24 Jun 2020 (UDI-DI 00847817007071), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00847817007071 | Date24 Jun 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK171664 | Date13 Sep 2017 | StatusActive |
Official records
- AccessGUDID record 00847817007071
- FDA 510(k) database K171664
Across registries
- FDA 510(k) K171664 decided 13 Sep 2017 Active
- FDA GUDID UDI-DI 00847817007071 listed 24 Jun 2020 Listed
Timeline
- Cleared FDA 510(k) K171664
- Listed FDA GUDID 00847817007071
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Hemoglobin Variants System
- Generic name
- Inherited haemoglobinopathy IVD, reagent
- Model / Ref / Catalog
- 250-0003, 2500003
- Primary DI / UDI-DI
- 00847817007071
- 510(k) Number
- FDA product code
- GKA
- GMDN term
- Inherited haemoglobinopathy IVD, reagent
- Device class
- Class II
- Regulation number
- 864.7415
- GUDID distribution status
- In Commercial Distribution
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- Primus Variant System PVS99 by Primus Corp.
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