Data / Medical devices / Enzyme Immunoassay, Tracrolimus
Enzyme Immunoassay, Tracrolimus (MLM): 11 FDA-registered makers in 4 countries
11 establishments in 4 countries are registered with the FDA to make Enzyme Immunoassay, Tracrolimus (product code MLM, Class 2, 21 CFR 862.1678). 8 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on January 27, 2023, and lists 12 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MLM
- Device class
- 2
- Regulation
- 862.1678
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Ireland | 2 |
| Germany | 2 |
| China | 1 |
Makers of Enzyme Immunoassay, Tracrolimus
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 |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer | 2 | November 4, 2015 | 0 | 5 | 0 | api.fda.gov |
| Abbott Ireland | Sligo, Ireland | Specification developer | 1 | August 1, 2007 | 0 | 0 | 0 | api.fda.gov |
| Abbott Laboratories | Abbott Park, IL, United States | Specification developer | 1 | August 1, 2007 | 0 | 2 | 0 | api.fda.gov |
| Microgenics Corporation | Fremont, CA, United States | Manufacturer | 1 | July 11, 2013 | 0 | 1 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer | 1 | November 6, 2018 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Yunze Biotechnology Co., Ltd. | Minhang Disctrict Shanghai, China | Manufacturer | 1 | January 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | April 6, 2006 | 0 | 2 | 0 | api.fda.gov |
| Waters Technologies Ireland, Ltd. | DRINAGH Wexford, Ireland | Specification developer | 1 | May 25, 2007 | 0 | 0 | 0 | api.fda.gov |
| Chromsystems Instruments & Chemicals GMBH | Gräfelfing Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fujirebio Diagnostics, Inc. | Malvern, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fujirebio Diagnostics, Inc. | Seguin, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 27, 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.