Analytab Products, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 5
What Analytab Products, Inc. makes
Analytab Products, Inc. manufactures microbiological culture media and diagnostic testing devices, including API UNISCEPT KB for bacterial identification, modified UNISCEPT KB labeling amendments, API GERM TUBE for microbial detection, and PENASE for penicillin susceptibility testing. Their portfolio also includes API UNISCEPT MIC and UNISCEPT MICRO-MIC systems for antimicrobial susceptibility testing.
The company’s products are regulated under FDA’s Class I and Class II device classifications, with several listed via the 510(k) pathway. These devices are intended for in vitro diagnostic use and are subject to compliance with U.S. regulatory requirements. The manufacturer operates from the United States.
Catalogue
Api Uniscept Kb Ref K912965
510(k) 510(k)Modified Uniscept Kb Labeling Amendment Ref K861408
510(k) 510(k)Api Germ Tube Ref K812862
510(k) 510(k)Penase Ref K812877
510(k) 510(k)Api Uniscept Mic/Uniscept Micro-Mic Ref K912964
510(k) 510(k)
Frequently asked questions
How many devices does Analytab Products, Inc. have in the registry?
The registry currently lists 5 devices for Analytab Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Analytab Products, Inc.'s devices?
Among its 5 most recently registered devices, Analytab Products, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Analytab Products, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Analytab Products, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Analytab Products, Inc. in the registry?
The most recently registered devices listed for Analytab Products, Inc. include API UNISCEPT KB, MODIFIED UNISCEPT KB LABELING AMENDMENT, API GERM TUBE and PENASE.