Gen Trak, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Gen Trak, Inc. makes
Gen Trak, Inc. manufactures monoclonal antibodies for flow cytometry applications, including CD8, CD4, and CD2 markers, as well as IgG2a and IgG1 isotype controls. These products are designed for use in laboratory testing to identify and quantify specific cell surface proteins in immunological assays.
The company’s portfolio is classified under FDA’s Class II medical devices and is subject to 510(k) clearance requirements. These products are listed in the FDA’s regulatory database, reflecting their authorised status for commercial distribution in the United States.
Catalogue
CD8 Monoclonal Antibodies Ref K914847
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
CD4 Monoclonal Antibodies Ref K914848
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
CD2 Monoclonal Antibodies Ref K914846
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gen Trak, Inc. have in the registry?
The registry currently lists 5 devices for Gen Trak, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gen Trak, Inc.'s devices?
Among its 5 most recently registered devices, Gen Trak, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Gen Trak, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Gen Trak, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gen Trak, Inc. in the registry?
The most recently registered devices listed for Gen Trak, Inc. include CD8 MONOCLONAL ANTIBODIES, MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOM, CD4 MONOCLONAL ANTIBODIES and MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM.