Technam, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Technam, Inc. makes
Technam, Inc. manufactures rapid diagnostic tests for detecting specific substances in biological samples, including methadone, morphine, and human chorionic gonadotropin (hCG). These tests are designed for point-of-care or laboratory use to identify the presence of these compounds in urine or serum samples.
The company’s portfolio is classified under FDA’s Class II medical devices and is authorised through the 510(k) premarket notification process. These devices are listed in the FDA’s regulatory database, and the manufacturer operates from the United States.
Catalogue
Hi-M-Test For Methadone Test #2 Ref K801509
Regimes: 510(k) Registry: 510(k)Hi-M-Test Morphine Ref K791551
Regimes: 510(k) Registry: 510(k)H-I-M-Test For Detecting Human Chor. Gon Ref K800055
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Technam, Inc. have in the registry?
The registry currently lists 3 devices for Technam, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Technam, Inc.'s devices?
Among its 3 most recently registered devices, Technam, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Technam, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Technam, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Technam, Inc. in the registry?
The most recently registered devices listed for Technam, Inc. include HI-M-TEST FOR METHADONE TEST #2, HI-M-TEST MORPHINE and H-I-M-TEST FOR DETECTING HUMAN CHOR. GON.