Data / Medical devices / Abnormal Hemoglobin Quantitation
Abnormal Hemoglobin Quantitation (GKA): 8 FDA-registered makers in 6 countries
8 establishments in 6 countries are registered with the FDA to make Abnormal Hemoglobin Quantitation (product code GKA, Class 2, 21 CFR 864.7415). 5 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 23 510(k) clearances under this code, the latest on April 4, 2024, and lists 6 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GKA
- Device class
- 2
- Regulation
- 864.7415
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| France | 1 |
| Finland | 1 |
| Japan | 1 |
| Switzerland | 1 |
| Brazil | 1 |
Makers of Abnormal Hemoglobin Quantitation
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 |
|---|---|---|---|---|---|---|---|---|
| Sebia | EVRY Essonne, France | Manufacturer | 7 | April 4, 2024 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Manufacturer, Specification developer | 3 | September 13, 2017 | 0 | 3 | 0 | api.fda.gov |
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer | 1 | April 19, 2022 | 0 | 0 | 0 | api.fda.gov |
| Trinity Biotech (Primus Corporation dba Trinity Biotech) | Kansas City, MO, United States | Manufacturer, Manufacturer for export | 1 | August 4, 2023 | 0 | 1 | 0 | api.fda.gov |
| Wallac OY | TURKU Varsinais-Suomi, Finland | Complaint file establishment, Manufacturer | 1 | March 8, 2006 | 0 | 0 | 0 | api.fda.gov |
| Oem Systems Co. Ltd. | UJI-SHI Kyoto, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trinity Biotech do Brasil | Extrema Minas Gerais, Brazil | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 4, 2024. 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.