Coretests, Inc.
United StatesFDA applicant, unverified
Coretests, Inc. is a medical device manufacturer, with 33 devices listed in FDA GUDID and FDA 510(k) (FDA Class II, Unclassified and Class I) as of 14 Nov 2026.
- Devices
- 33
Registry facts
- Registries
- FDA GUDID 31
- FDA 510(k) 2
- Device classes
- FDA Class II 18
- FDA Unclassified 13
- FDA Class I 2
- Identifiers
- DUNS 036440919
Catalogue
Search and filter all 33 devicesCompany details
- DUNS number
- 036440919
Frequently asked questions
How many devices does CORETESTS, INC. have in the registry?
The registry currently lists 33 devices for CORETESTS, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list CORETESTS, INC.'s devices?
Among its 33 most recently registered devices, CORETESTS, INC. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (31 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do CORETESTS, INC.'s devices fall under?
Among its 33 most recently registered devices, the classes recorded for CORETESTS, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from CORETESTS, INC. in the registry?
The most recently registered devices listed for CORETESTS, INC. include One Step hCG Pregnancy Test, CorDx Tyfast ACT21002-5, CorDx Tyfast ACT21002-1 and CorDx CO291-5.