Clinical Standards Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Clinical Standards Laboratories, Inc. makes
Clinical Standards Laboratories, Inc. manufactures diagnostic test media, including the *Haemophilus Test Medium (HTM)* for culturing *Haemophilus influenzae* and the *Strep-Sure A/E* for detecting group A and group E streptococci in clinical specimens.
These products are regulated as Class I and Class II medical devices under FDA 510(k) clearance requirements and are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Haemophilus Test Medium (Htm) Ref K952595
Regimes: 510(k) Registry: 510(k)Strep-Sure A/E Ref K941111
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Clinical Standards Laboratories, Inc. have in the registry?
The registry currently lists 2 devices for Clinical Standards Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Clinical Standards Laboratories, Inc.'s devices?
Among its 2 most recently registered devices, Clinical Standards Laboratories, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Clinical Standards Laboratories, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Clinical Standards 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 Clinical Standards Laboratories, Inc. in the registry?
The most recently registered devices listed for Clinical Standards Laboratories, Inc. include HAEMOPHILUS TEST MEDIUM (HTM) and STREP-SURE A/E.