Data / Medical devices / Hemoglobin A2 Quantitation
Hemoglobin A2 Quantitation (JPD): 4 FDA-registered makers in 3 countries
4 establishments in 3 countries are registered with the FDA to make Hemoglobin A2 Quantitation (product code JPD, Class 2, 21 CFR 864.7400). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on May 14, 2002, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- JPD
- Device class
- 2
- Regulation
- 864.7400
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| Japan | 2 |
| United States | 1 |
| Singapore | 1 |
Makers of Hemoglobin A2 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 |
|---|---|---|---|---|---|---|---|---|
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Manufacturer, Manufacturer for export | 1 | June 10, 1999 | 0 | 2 | 0 | api.fda.gov |
| Bio-Rad Laboratories (Singapore) Pte. Ltd. | Singapore Central Singapore, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oem Systems Co. Ltd. | UJI-SHI Kyoto, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tosoh Hi-Tec, Inc. | Yamaguchi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 14, 2002. 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.