Photec Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 12
What Photec Diagnostics, Inc. makes
Photec Diagnostics, Inc. manufactures in-vitro diagnostic (IVD) test kits and analyzers for measuring lipid profiles, apolipoproteins, and thyroid hormones. Their products include whole blood and serum/plasma analyzers for cholesterol, triglycerides, and HDL-apolipoprotein A-1, alongside immunoassay test sets for apolipoprotein A1 and thyroid markers like thyroxine. The company also provides calibrators, controls, and specialized test kits for specific biochemical measurements, such as theophylline and T-uptake assays.
The company’s diagnostic devices are classified under FDA’s Class I and Class II categories, requiring regulatory clearance via the 510(k) pathway. These products are listed in the FDA’s 510(k) database, adhering to U.S. regulatory standards for in-vitro diagnostics. The manufacturer operates from the United States, where its devices are subject to compliance with the Federal Food, Drug, and Cosmetic Act.
Catalogue
Search and filter all 12 devicesFrequently asked questions
How many devices does Photec Diagnostics, Inc. have in the registry?
The registry currently lists 12 devices for Photec Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Photec Diagnostics, Inc.'s devices?
Among its 12 most recently registered devices, Photec Diagnostics, Inc. has devices listed in FDA 510(k) (12 devices).
What risk classes do Photec Diagnostics, Inc.'s devices fall under?
Among its 12 most recently registered devices, the classes recorded for Photec Diagnostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Photec Diagnostics, Inc. in the registry?
The most recently registered devices listed for Photec Diagnostics, Inc. include APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1, QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA, D-CHEM and QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD.