Data / Medical devices / Human Metapneumovirus (Hmpv) Rna Assay System
Human Metapneumovirus (Hmpv) Rna Assay System (OEM): 13 FDA-registered makers in 5 countries
13 establishments in 5 countries are registered with the FDA to make Human Metapneumovirus (Hmpv) Rna Assay System (product code OEM, Class 2, 21 CFR 866.3980). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on March 10, 2023, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- OEM
- Device class
- 2
- Regulation
- 866.3980
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Hungary | 1 |
| Malaysia | 1 |
| China | 1 |
| Canada | 1 |
Makers of Human Metapneumovirus (Hmpv) Rna Assay 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 |
|---|---|---|---|---|---|---|---|---|
| Abbott Diagnostics Scarborough, Inc. | Scarborough, ME, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Applied BioCode, Inc. | Santa Fe Springs, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BioFire Diagnostics, LLC | Salt Lake City, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DIAMOND DIAGNOSTICS Inc | Holliston, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diamond Diagnostics Inc. | Budapest, Hungary | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genmark Diagnostics, Inc. | Carlsbad, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hochuen Medical Sdn. Bhd. | SENAI Johor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hochuen Medical Technology Co.,Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hologic, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Luminex Molecular Diagnostics, Inc. | TORONTO Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Luminex Corporation | Austin, TX, United States | Complaint file establishment, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Luminex Corporation | Northbrook, IL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Athens, OH, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 10, 2023. 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.