Data / Medical devices / Mmp-9 Test System
Mmp-9 Test System (PFQ): 5 FDA-registered makers in 3 countries
5 establishments in 3 countries are registered with the FDA to make Mmp-9 Test System (product code PFQ, Class 1, 21 CFR 862.1540). 3 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on November 21, 2013, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PFQ
- Device class
- 1
- Regulation
- 862.1540
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Mexico | 1 |
| China | 1 |
Makers of Mmp-9 Test System
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 |
|---|---|---|---|---|---|---|---|---|
| Ortho-Clinical Diagnostics, Inc. | San Diego, CA, United States | Specification developer | 1 | November 21, 2013 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Carlsbad, CA, United States | Manufacturer | 1 | November 21, 2013 | 0 | 0 | 0 | api.fda.gov |
| Quidel Corp. | San Diego, CA, United States | Complaint file establishment, Manufacturer | 1 | November 21, 2013 | 0 | 2 | 0 | api.fda.gov |
| Integra Biotechnical, SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhide Mingchuang Biotechnology (wuxi) Co., Ltd. | Wuxi Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 21, 2013. 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.