Immuchem Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 18
What Immuchem Corp. makes
Immuchem Corp. manufactures diagnostic radioimmunoassay (RIA) kits and immunoradiometric assay (IRMA) reagents for measuring hormones and biomarkers, including luteinizing hormone (LH), estradiol, thyroid-stimulating hormone (TSH), follicle-stimulating hormone (FSH), testosterone, and androstenedione. Their products include solid-phase assays, covalent-coat binding systems, and neonatal-specific TSH tests, designed for laboratory use in hormone level analysis.
The company’s diagnostic assays are classified under FDA’s Class I and Class II regulatory categories, with relevant devices listed via the 510(k) pathway. These products are intended for in vitro diagnostic use and comply with U.S. regulatory requirements. The manufacturer is based in the United States.
Catalogue
Search and filter all 18 devicesFrequently asked questions
How many devices does Immuchem Corp. have in the registry?
The registry currently lists 18 devices for Immuchem Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Immuchem Corp.'s devices?
Among its 18 most recently registered devices, Immuchem Corp. has devices listed in FDA 510(k) (18 devices).
What risk classes do Immuchem Corp.'s devices fall under?
Among its 18 most recently registered devices, the classes recorded for Immuchem Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Immuchem Corp. in the registry?
The most recently registered devices listed for Immuchem Corp. include LUTEINIZING HORMONE (LH-IRMA) RIA KIT, ESTRADIOL KIT BY RIA, THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL and IMMUCHEM COVALENT COAT SOLID PHASE ASSAY.