Enzo Biochem, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Enzo Biochem, Inc. makes
Enzo Biochem, Inc. manufactures in vitro diagnostic tests for detecting cytomegalovirus (CMV) and herpes simplex virus (HSV) DNA via fluorescent and chromogenic hybridization assays, as well as a fecal occult blood test for detecting gastrointestinal bleeding. These tests are designed for laboratory use to confirm viral infections and screen for blood in stool samples.
The company’s diagnostic tests are classified as Class II devices under FDA regulations and are authorised through the 510(k) clearance process. These products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Hemagel(Tm) Test For Fecal Occult Blood Ref K881907
Regimes: 510(k) Registry: 510(k)Colorgene Hsv Dna Hybridization Test Ref K880604
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Enzo Biochem, Inc. have in the registry?
The registry currently lists 5 devices for Enzo Biochem, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Enzo Biochem, Inc.'s devices?
Among its 5 most recently registered devices, Enzo Biochem, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Enzo Biochem, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Enzo Biochem, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Enzo Biochem, Inc. in the registry?
The most recently registered devices listed for Enzo Biochem, Inc. include COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION, COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV, HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD and COLORGENE HSV DNA HYBRIDIZATION TEST.