Data / Medical devices / Whole Human Serum, Antigen, Antiserum, Control
Whole Human Serum, Antigen, Antiserum, Control (DGR): 10 FDA-registered makers in 5 countries
10 establishments in 5 countries are registered with the FDA to make Whole Human Serum, Antigen, Antiserum, Control (product code DGR, Class 1, 21 CFR 866.5700). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on September 24, 1996, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DGR
- Device class
- 1
- Regulation
- 866.5700
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Israel | 2 |
| Denmark | 1 |
| Singapore | 1 |
| France | 1 |
Makers of Whole Human Serum, Antigen, Antiserum, Control
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 |
|---|---|---|---|---|---|---|---|---|
| Agilent Technologies Denmark ApS | GLOSTRUP Hovedstaden, Denmark | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Agilent Technologies Singapore (International) Pte Ltd. | Singapore North East, Singapore | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Glycominds Diagnostics (2014) Ltd. | Raanana Central, Israel | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hemo Bioscience | Durham, NC, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immco Diagnostics, Inc. | Williamsville, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kent Laboratories, Inc. | Bellingham, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Raritan, NJ, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Savyon Diagnostics Ltd. | ASHDOD Southern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Theradiag | MARNE LA VALLEE CEDEX 2 Seine-et-Marne, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 24, 1996. 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.