Data / Medical devices / Albumin, Fitc, Antigen, Antiserum, Control
Albumin, Fitc, Antigen, Antiserum, Control (DDZ): 11 FDA-registered makers in 6 countries
11 establishments in 6 countries are registered with the FDA to make Albumin, Fitc, Antigen, Antiserum, Control (product code DDZ, Class 2, 21 CFR 866.5040). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on April 21, 2005, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DDZ
- Device class
- 2
- Regulation
- 866.5040
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| United Kingdom | 2 |
| China | 2 |
| Denmark | 1 |
| Singapore | 1 |
| India | 1 |
Makers of Albumin, Fitc, 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 | 1 | July 18, 1983 | 0 | 0 | 0 | api.fda.gov |
| Agilent Technologies Singapore (International) Pte Ltd. | Singapore North East, Singapore | Specification developer | 1 | July 18, 1983 | 0 | 0 | 0 | api.fda.gov |
| Horiba Instruments Incorporated | Canton, MI, United States | Manufacturer | 1 | April 28, 2003 | 0 | 0 | 0 | api.fda.gov |
| Randox Laboratories Limited | CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Contract manufacturer, Manufacturer | 1 | October 5, 2000 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou Rollmed Co.,ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| High Technology, Inc. | North Attleboro, MA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kent Laboratories, Inc. | Bellingham, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lords Mark Industries Ltd. | Daman and Diu Dadra and Nagar Haveli, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Randox Laboratories Limited | ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shijiazhuang Hipro Biotechnology Co.,ltd | Shijiazhuang Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 21, 2005. 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.