Micro Diagnostics Corp.
United StatesFDA applicant, unverified
- Devices
- 11
What Micro Diagnostics Corp. makes
Micro Diagnostics Corp. manufactures rapid diagnostic tests for detecting drug metabolites, including immunoassay strips and enzyme-linked immunoassay (EIA) formats. Their products target specific substances such as phenyclidine, opiates, amphetamines, marijuana, and cocaine metabolites, as well as a multi-test strip for drugs of abuse. The company also produces the SPUNCRIT (Model DRC-40), a device for critical care applications.
These devices are regulated under FDA Class II and Class U classifications, with most requiring 510(k) clearance. The products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Search and filter all 11 devicesFrequently asked questions
How many devices does Micro Diagnostics Corp. have in the registry?
The registry currently lists 11 devices for Micro Diagnostics Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Micro Diagnostics Corp.'s devices?
Among its 11 most recently registered devices, Micro Diagnostics Corp. has devices listed in FDA 510(k) (11 devices).
What risk classes do Micro Diagnostics Corp.'s devices fall under?
Among its 11 most recently registered devices, the classes recorded for Micro Diagnostics Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Micro Diagnostics Corp. in the registry?
The most recently registered devices listed for Micro Diagnostics Corp. include MICRO-STRIP FOR PHENCYCLIDINE METABOLITES, MICRO EIA FOR OPIATE METABOLITES, MICRO-STRIP FOR AMPHETAMINE METABOLITES and MICRO EIA FOR AMPHETAMINE METABOLITES.