Data / Medical devices / Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
Nad-Nadh, Specific Reagent For Alcohol Enzyme Method (DML): 5 FDA-registered makers in 3 countries
5 establishments in 3 countries are registered with the FDA to make Nad-Nadh, Specific Reagent For Alcohol Enzyme Method (product code DML, Class 2, 21 CFR 862.3040). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on December 14, 2001, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DML
- Device class
- 2
- Regulation
- 862.3040
- Medical specialty
- Clinical Toxicology
Makers by country
| Country | Makers |
|---|---|
| Germany | 2 |
| United States | 2 |
| Switzerland | 1 |
Makers of Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
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 |
|---|---|---|---|---|---|---|---|---|
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer | 1 | August 24, 1995 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer | 1 | February 1, 2000 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | February 1, 2000 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | PENZBERG Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 14, 2001. 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.