Data / Medical devices / Cryptosporidium Spp.
Cryptosporidium Spp. (MHJ): 12 FDA-registered makers in 3 countries
12 establishments in 3 countries are registered with the FDA to make Cryptosporidium Spp. (product code MHJ, Class 2, 21 CFR 866.3220). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on July 10, 2017, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MHJ
- Device class
- 2
- Regulation
- 866.3220
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| United Kingdom | 2 |
| Germany | 1 |
Makers of Cryptosporidium Spp.
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 |
|---|---|---|---|---|---|---|---|---|
| Techlab, Inc. | Radford, VA, United States | Manufacturer | 3 | July 10, 2017 | 0 | 0 | 0 | api.fda.gov |
| Techlab, Inc. | Blacksburg, VA, United States | Manufacturer | 3 | July 10, 2017 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 1 | July 10, 2003 | 0 | 0 | 0 | api.fda.gov |
| Medical Chemical Corporation | Torrance, CA, United States | Manufacturer, Repackager or relabeler | 1 | July 10, 2003 | 0 | 0 | 0 | api.fda.gov |
| Oxoid, Ltd. | Basingstoke, Hampshire, United Kingdom | Exporter to the US, Specification developer | 1 | September 3, 1998 | 0 | 0 | 0 | api.fda.gov |
| Remel, Inc. | Lenexa, KS, United States | Manufacturer | 1 | November 14, 2003 | 0 | 1 | 0 | api.fda.gov |
| Aceso Laboratories Inc. | Chino, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivd Research, LLC. | Carlsbad, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remel Europe Ltd | Dartford, Kent, United Kingdom | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 10, 2017. 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.