Hemoglobin Variants System 250-0016
Hemoglobin Variants System 250-0016 (2500016) 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 00847817007187), 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 | Number00847817007187 | Date24 Jun 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK171664 | Date13 Sep 2017 | StatusActive |
Official records
- AccessGUDID record 00847817007187
- FDA 510(k) database K171664
Across registries
- FDA 510(k) K171664 decided 13 Sep 2017 Active
- FDA GUDID UDI-DI 00847817007187 listed 24 Jun 2020 Listed
Timeline
- Cleared FDA 510(k) K171664
- Listed FDA GUDID 00847817007187
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Hemoglobin Variants System
- Generic name
- Inherited haemoglobinopathy IVD, control
- Model / Ref / Catalog
- 250-0016, 2500016
- Primary DI / UDI-DI
- 00847817007187
- 510(k) Number
- FDA product code
- GKA
- GMDN term
- Inherited haemoglobinopathy IVD, control
- Device class
- Class II
- Regulation number
- 864.7415
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code GKA (ABNORMAL HEMOGLOBIN QUANTITATION).
- VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH by Bio-Rad Laboratories, Inc., Clinical Systems Divis
- Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software by Bio-Rad Laboratories, Inc.
- RESOLVE-HB by Isolab, Inc.
- SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 by SEBIA
- Primus Variant System PVS99 by Primus Corp.
- Variant Hemoglobinopathy Program by Bio-Rad
- Variant NBS Sickle Cell Program by Bio-Rad Laboratories, Inc.
- VARIANT SICKLE CELL SHORT PROGRAM by Bio-Rad
- CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument by SEBIA
- ISOPROPANOL HEMOGLOBIN STABILITY TEST by Helena Laboratories, Corp.