Breit Laboratories, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 5
What Breit Laboratories, Inc. makes
Breit Laboratories, Inc. manufactures in vitro diagnostic tests for detecting occult blood, rheumatoid factor, and autoimmune markers. Their portfolio includes the COLOTRAK Occult Blood Test, IGM Rheumatoid Factor Test Kit, Antinuclear Antibody Test Kit, Anti-N DNA Antibody Test Kit, and a standalone Occult Blood Test. These products are designed for laboratory use to aid in diagnosing conditions such as gastrointestinal bleeding and autoimmune diseases.
The company’s diagnostic tests are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. Their products are intended for use in the United States, where regulatory compliance is required for in vitro diagnostics. No other registries or jurisdictions are referenced in their device listings.
Catalogue
Colotrak Occult Blood Test Ref K840527
510(k) 510(k)Igm Rheumatoid Factor Test Kit Ref K851099
510(k) 510(k)Antinuclear Antibody Test Kit Ref K831927
510(k) 510(k)Anti-N Dna Antibody Test Kit Ref K832031
510(k) 510(k)Occult Blood Test Ref K842137
510(k) 510(k)
Frequently asked questions
How many devices does Breit Laboratories, Inc. have in the registry?
The registry currently lists 5 devices for Breit Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Breit Laboratories, Inc.'s devices?
Among its 5 most recently registered devices, Breit Laboratories, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Breit Laboratories, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Breit Laboratories, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Breit Laboratories, Inc. in the registry?
The most recently registered devices listed for Breit Laboratories, Inc. include COLOTRAK OCCULT BLOOD TEST, IGM RHEUMATOID FACTOR TEST KIT, ANTINUCLEAR ANTIBODY TEST KIT and ANTI-N DNA ANTIBODY TEST KIT.