Data / Medical devices / Enzyme Immunoassay, Phenobarbital
Enzyme Immunoassay, Phenobarbital (DLZ): 18 FDA-registered makers in 6 countries
18 establishments in 6 countries are registered with the FDA to make Enzyme Immunoassay, Phenobarbital (product code DLZ, Class 2, 21 CFR 862.3660). 10 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 35 510(k) clearances under this code, the latest on August 13, 2021, and lists 9 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DLZ
- Device class
- 2
- Regulation
- 862.3660
- Medical specialty
- Clinical Toxicology
Makers by country
| Country | Makers |
|---|---|
| United States | 11 |
| Germany | 3 |
| Japan | 1 |
| United Kingdom | 1 |
| Ireland | 1 |
| Switzerland | 1 |
Makers of Enzyme Immunoassay, Phenobarbital
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, Specification developer | 3 | June 6, 2001 | 0 | 3 | 0 | api.fda.gov |
| Microgenics Corporation | Fremont, CA, United States | Contract manufacturer, Manufacturer | 2 | April 26, 2013 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 2 | July 2, 2001 | 0 | 0 | 0 | api.fda.gov |
| B.R.A.H.M.S GmbH | HENNIGSDORF Brandenburg, Germany | Specification developer | 1 | April 26, 2013 | 0 | 0 | 0 | api.fda.gov |
| Denka Co., Ltd. | GOSEN-SHI Niigata, Japan | Manufacturer | 1 | September 26, 2008 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | August 13, 2021 | 0 | 3 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer | 1 | August 13, 2021 | 0 | 0 | 0 | api.fda.gov |
| Randox Laboratories Limited | CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Contract manufacturer, Manufacturer | 1 | July 2, 2001 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer | 1 | September 12, 2007 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 1 | July 2, 2001 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Manufacturer, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter Ireland Inc | O CALLAGHANS MILLS Clare, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Currier Plastics | Auburn, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nypro Inc. (Chicago) | Gurnee, IL, United States | Contract manufacturer | 0 | 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 August 13, 2021. 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.