Amedica Biotech, Inc.
United StatesFDA applicant, unverified
- Devices
- 13
What Amedica Biotech, Inc. makes
Amedica Biotech, Inc. manufactures rapid drug screening devices, including single- and multi-panel tests for substances such as THC, cocaine, methamphetamine, PCP, amphetamines, benzodiazepines, MDMA, and opioids. Products include standalone test cups for specific drugs (e.g., phencyclidine, MDMA/BZO combinations) and comprehensive panels covering multiple classes of controlled substances. Some models are designed for high-throughput screening, such as the C1010 series or OP1300, which detect a broader range of drugs in a single test.
These devices are classified as Class II or unclassified under FDA regulations and are authorised via the 510(k) pathway. They are listed in the FDA’s 510(k) database. The company is headquartered in the United States.
Catalogue
Search and filter all 13 devicesFrequently asked questions
How many devices does Amedica Biotech, Inc. have in the registry?
The registry currently lists 13 devices for Amedica Biotech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Amedica Biotech, Inc.'s devices?
Among its 13 most recently registered devices, Amedica Biotech, Inc. has devices listed in FDA 510(k) (13 devices).
What risk classes do Amedica Biotech, Inc.'s devices fall under?
Among its 13 most recently registered devices, the classes recorded for Amedica Biotech, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Amedica Biotech, Inc. in the registry?
The most recently registered devices listed for Amedica Biotech, Inc. include AMEDICA DRUG SCREEN TEST CUP, AMEDICA DRUG SCREEN PHENCYCLIDINE TEST, AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST and AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA.