Data / Medical devices / Kit, Direct Antigen, Positive Control
Kit, Direct Antigen, Positive Control (MJZ): 11 FDA-registered makers in 4 countries
11 establishments in 4 countries are registered with the FDA to make Kit, Direct Antigen, Positive Control (product code MJZ, Class 1, 21 CFR 862.1660). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on September 1, 2009, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MJZ
- Device class
- 1
- Regulation
- 862.1660
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| China | 3 |
| India | 1 |
| South Korea | 1 |
Makers of Kit, Direct Antigen, Positive 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 |
|---|---|---|---|---|---|---|---|---|
| Abbott Diagnostics Scarborough, Inc. | Scarborough, ME, United States | Manufacturer | 1 | September 1, 2009 | 0 | 0 | 0 | api.fda.gov |
| Abbott Diagnostics Scarborough, Inc. | Westbrook, ME, United States | Manufacturer | 1 | September 1, 2009 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou Guangdong, China | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Wondfo Biotech Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Healgen Scientific LLC | Houston, TX, United States | Complaint file establishment, Specification developer | 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 | |
| Nano-Ditech Corporation | Cranbury, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OSANG Healthcare CO., LTD. | ANYANG Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STS Corporation | Duluth, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wondfo USA Co., Ltd. | San Diego, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Orient Gene Biotech | Huzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 1, 2009. 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.