Ventrex Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 82
What Ventrex Laboratories, Inc. makes
Ventrex Laboratories, Inc. manufactures in vitro diagnostic (IVD) test kits and reagents for clinical laboratory use, including immunoassays for hormones (e.g., HCG, TSH, T3 uptake), allergens, and infectious agents (e.g., Streptococcus A). Their portfolio also covers radioimmunoassay (RIA) and enzyme-linked immunosorbent assay (EIA) controls, as well as microvial test sets for biochemical markers like ACE activity and vitamin B12/folate levels.
The company’s products are regulated under FDA’s 510(k) clearance process, with devices classified as Class I (general controls) and Class II (special controls). These tests are listed in the FDA’s 510(k) registry, reflecting their authorised status for clinical diagnostic use in the United States.
Catalogue
Search and filter all 82 devicesShowing 1-50 of 82
Frequently asked questions
How many devices does Ventrex Laboratories, Inc. have in the registry?
The registry currently lists 82 devices for Ventrex Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ventrex Laboratories, Inc.'s devices?
Among its 50 most recently registered devices, Ventrex Laboratories, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Ventrex Laboratories, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Ventrex Laboratories, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ventrex Laboratories, Inc. in the registry?
The most recently registered devices listed for Ventrex Laboratories, Inc. include VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY, ACE ACTIVITY MICROVIAL TEST SET, CENTRIA T3 UPTAKE TEST SET and VENTRESCREEN, MULTIPLE ALLERGEN DISCS.