Tcpi, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 14
What Tcpi, Inc. makes
Tcpi, Inc. manufactures rapid diagnostic test strips and reagents for at-home and clinical use, including pregnancy tests (HCG-based), urine protein and glucose screening, and drug-of-abuse tests for substances such as cocaine, opiates, benzodiazepines, cannabinoids, amphetamines, and PCP. The company also produces urine nitrite tests and serum diluent reagents for pregnancy testing.
These devices are regulated under the FDA’s Class I and Class II classifications, with some falling under the Unclassified (U) category, and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Search and filter all 14 devicesFrequently asked questions
How many devices does Tcpi, Inc. have in the registry?
The registry currently lists 14 devices for Tcpi, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tcpi, Inc.'s devices?
Among its 14 most recently registered devices, Tcpi, Inc. has devices listed in FDA 510(k) (14 devices).
What risk classes do Tcpi, Inc.'s devices fall under?
Among its 14 most recently registered devices, the classes recorded for Tcpi, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Tcpi, Inc. in the registry?
The most recently registered devices listed for Tcpi, Inc. include ONE STEP LH TEST, HCG PREGNANCY ONE STEP TEST STRIP, ONE STEP URINE DRUG OF ABUSE COCAINE TEST and HEALTH CHECK URI-TEST PROTEIN IN URINE.