Data / Medical devices / Kinetic Method, Gamma-Glutamyl Transpeptidase / United States
FDA-registered makers of Kinetic Method, Gamma-Glutamyl Transpeptidase in the United States: 15 establishments
15 establishments in the United States are registered with the FDA to make Kinetic Method, Gamma-Glutamyl Transpeptidase (product code JQB). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Kinetic Method, Gamma-Glutamyl Transpeptidase
- Product code
- JQB
- Country
- United States
Makers of Kinetic Method, Gamma-Glutamyl Transpeptidase in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cliniqa Corporation | San Marcos, CA, United States | Manufacturer | 1 | December 20, 1990 | 0 | 0 | 0 | api.fda.gov |
| Fisher Diagnostics | Middletown, VA, United States | Manufacturer | 1 | November 19, 1991 | 0 | 0 | 0 | api.fda.gov |
| Horiba Instruments Incorporated | Canton, MI, United States | Manufacturer | 1 | October 10, 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 |
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer | 1 | May 27, 1988 | 0 | 0 | 0 | api.fda.gov |
| Abaxis, Inc. | Union City, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bialex Lab | Wichita Falls, TX, United States | Manufacturer, Manufacturer for export | 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 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stanbio Laboratory | Boerne, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.