Immulok, Inc.
United StatesFDA applicant, unverified
- Devices
- 15
What Immulok, Inc. makes
Immulok, Inc. manufactures diagnostic reagents and kits for laboratory testing, including immunofluorescent antibodies for detecting pathogens like *Toxoplasma gondii* and *Herpes simplex virus*, as well as culture sets for isolating *Chlamydia*. The company also produces immunoperoxidase tissue kits for histological analysis, viral transport systems, and radioimmunoassay (RIA) kits, such as the proactin RIA kit. Additional products include substrates for antinuclear antibody testing and specific antibody reagents for IgG, IgA, and IgM detection.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded via the 510(k) pathway. These products are intended for in vitro diagnostic use and are listed in the FDA’s regulatory database. Immulok, Inc. is headquartered in the United States.
Catalogue
Search and filter all 15 devicesFrequently asked questions
How many devices does Immulok, Inc. have in the registry?
The registry currently lists 15 devices for Immulok, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Immulok, Inc.'s devices?
Among its 15 most recently registered devices, Immulok, Inc. has devices listed in FDA 510(k) (15 devices).
What risk classes do Immulok, Inc.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for Immulok, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Immulok, Inc. in the registry?
The most recently registered devices listed for Immulok, Inc. include FLUOROSET IMMUNOFLUORESCENT ANTIBODY, CULUTURE SET CHLAMYDIA ISOLATION AND, IMMULOK CULTURESET and TOXOPLASMA GONDII ANTIBODY IGG.