Data / Medical devices / Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes / United States
FDA-registered makers of Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes in the United States: 16 establishments
16 establishments in the United States are registered with the FDA to make Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE). 9 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
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- Device
- Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- Product code
- CJE
- Country
- United States
Makers of Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer, Manufacturer | 3 | April 18, 1988 | 0 | 0 | 0 | api.fda.gov |
| Alfa Wassermann | West Caldwell, NJ, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 2 | August 15, 2013 | 0 | 0 | 0 | api.fda.gov |
| Horiba Instruments Incorporated | Canton, MI, United States | Manufacturer | 2 | October 22, 1997 | 0 | 2 | 0 | api.fda.gov |
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer | 2 | January 20, 2000 | 0 | 0 | 0 | api.fda.gov |
| Abbott Laboratories | Irving, TX, United States | Specification developer | 1 | December 26, 2002 | 0 | 0 | 0 | api.fda.gov |
| Cliniqa Corporation | San Marcos, CA, United States | Manufacturer | 1 | September 12, 1983 | 0 | 0 | 0 | api.fda.gov |
| Carolina Liquid Chemistries | Brea, CA, United States | Manufacturer | 1 | February 4, 1997 | 0 | 0 | 0 | api.fda.gov |
| Infrared Laboratory Systems dba SYNERMED | Westfield, IN, United States | Manufacturer | 1 | September 8, 1993 | 0 | 0 | 0 | api.fda.gov |
| Stanbio Laboratory | Boerne, TX, United States | Manufacturer | 1 | May 17, 1994 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| High Technology, Inc. | North Attleboro, MA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medica Corp. | Bedford, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.