Data / Medical devices / Kit, Serological, Positive Control
Kit, Serological, Positive Control (MJX): 9 FDA-registered makers in 4 countries
9 establishments in 4 countries are registered with the FDA to make Kit, Serological, Positive Control (product code MJX, Class 1, 21 CFR 862.1660). 3 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on July 22, 2010, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MJX
- Device class
- 1
- Regulation
- 862.1660
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| United Kingdom | 1 |
| Germany | 1 |
| China | 1 |
Makers of Kit, Serological, 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 |
|---|---|---|---|---|---|---|---|---|
| LGC Clinical Diagnostics, Inc. | Milford, MA, United States | Manufacturer | 1 | October 8, 1997 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | January 17, 2003 | 0 | 1 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics | Pencoed Bridgend, United Kingdom | Complaint file establishment, Manufacturer | 1 | January 17, 2003 | 0 | 0 | 0 | api.fda.gov |
| Aalto Scientific Ltd. | Eatonton, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ABBOTT GmbH | Wiesbaden Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CTK Biotech, Inc. | Poway, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meridian Bioscience, Inc. | Cincinnati, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd. | shenzhen Guangdong, China | 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 |
Updated July 22, 2010. 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.