Vxr, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 8
What Vxr, Inc. makes
Vxr, Inc. manufactures in vitro diagnostic tests for urine and blood assays, including pregnancy detection kits, human chorionic gonadotropin (HCG) urine tests, and enzyme immunoassays for theophylline, thyroid hormones (T3, T4), and digoxin. Their portfolio also includes enzyme immunoassay controls for laboratory use.
These diagnostic devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States and its products are listed in the FDA’s 510(k) registry.
Catalogue
Ventrescreen Hcg Urine Ref K853748
510(k) 510(k)Ventrezyme Theophylline Immunoassay Ref K833989
510(k) 510(k)Ventrescreen Beta-Hcg Enzyme Immuno Ref K833909
510(k) 510(k)Ventrex Pregnancy Test Kit Enzyme Ref K833960
510(k) 510(k)Ventrezyme T3 Immunoassay T3 Ref K853703
510(k) 510(k)Ventrezyme Digoxin Immunoassay Digox Ref K833878
510(k) 510(k)Ventrezyme T4 Immunoassay T4 Ref K840473
510(k) 510(k)Ventrexyme Eia Controls Immunoassay Ref K841456
510(k) 510(k)
Frequently asked questions
How many devices does Vxr, Inc. have in the registry?
The registry currently lists 8 devices for Vxr, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vxr, Inc.'s devices?
Among its 8 most recently registered devices, Vxr, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Vxr, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Vxr, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Vxr, Inc. in the registry?
The most recently registered devices listed for Vxr, Inc. include VENTRESCREEN HCG URINE, VENTREZYME THEOPHYLLINE IMMUNOASSAY, VENTRESCREEN BETA-HCG ENZYME IMMUNO and VENTREX PREGNANCY TEST KIT ENZYME.