Data / Medical devices / Kit, Identification, Mycobacteria
Kit, Identification, Mycobacteria (JSY): 6 FDA-registered makers in 2 countries
6 establishments in 2 countries are registered with the FDA to make Kit, Identification, Mycobacteria (product code JSY, Class 1, 21 CFR 866.2660). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on March 13, 1995, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JSY
- Device class
- 1
- Regulation
- 866.2660
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| China | 2 |
Makers of Kit, Identification, Mycobacteria
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 |
|---|---|---|---|---|---|---|---|---|
| CalibreScientific US, Inc. | Vancouver, WA, United States | Manufacturer | 1 | March 24, 1988 | 0 | 0 | 0 | api.fda.gov |
| Beijing Genesee Biotech, Inc. | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bialex Lab | Wichita Falls, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethos Biosciences, INC. | Logan Township, NJ, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Lysun Biotechnology Co.ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polysciences, Inc. | Warrington, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 13, 1995. 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.