Psychemedics Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 19
What Psychemedics Corp. makes
Psychemedics Corp. manufactures immunoassay kits for detecting and quantifying controlled substances, including phencyclidine, opioids, cocaine, methamphetamine, MDMA, cannabinoids, and their metabolites in biological samples. These assays include enzyme-linked immunosorbent assays (EIA) and radioimmunoassays (RIA), designed for laboratory use in drug testing and forensic analysis. The portfolio also includes microplate-based EIA formats for specific targets like oxycodone and morphine in hair samples.
The company’s products are regulated under FDA Class II and Class U device classifications, with many authorised via the 510(k) pathway. These assays are listed in the FDA’s 510(k) database and are intended for use in the United States. The manufacturer is based in the US.
Catalogue
Search and filter all 19 devicesFrequently asked questions
How many devices does Psychemedics Corp. have in the registry?
The registry currently lists 19 devices for Psychemedics Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Psychemedics Corp.'s devices?
Among its 19 most recently registered devices, Psychemedics Corp. has devices listed in FDA 510(k) (19 devices).
What risk classes do Psychemedics Corp.'s devices fall under?
Among its 19 most recently registered devices, the classes recorded for Psychemedics Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Psychemedics Corp. in the registry?
The most recently registered devices listed for Psychemedics Corp. include PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair, PSYCHEMEDICS OPIATES EIA and PSYCHEMEDICS COCAINE EIA.