Clinetics Corp.
United StatesFDA applicant, unverified
- Devices
- 9
What Clinetics Corp. makes
Clinetics Corp. manufactures diagnostic in vitro diagnostic (IVD) kits and reagents for hormone and immunoglobulin testing, including radioimmunoassay (RIA) kits for human chorionic gonadotropin (HCG), thyroid-stimulating hormone (TSH) receptor antibodies, adrenocorticotropic hormone (ACTH), follicle-stimulating hormone (FSH), luteinizing hormone (LH), and immunoglobulin subclasses D and E. Their portfolio also includes specialized columns for peptide and protein analysis, such as the Clinetics PCA Column, and combined assay kits for simultaneous hormone measurements.
The company’s products are regulated under the U.S. Food and Drug Administration (FDA) as Class I and Class II in vitro diagnostic devices, with some cleared via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. regulatory requirements. The manufacturer operates from the United States.
Catalogue
Hcg Beta Ria Kit Ref K822152
Regimes: 510(k) Registry: 510(k)Tsh Receptor Antibody Kit 125I Tsh Ref K841580
Regimes: 510(k) Registry: 510(k)Adrenocorticotropic Hormone Test Ref K833934
Regimes: 510(k) Registry: 510(k)125-I Fsh Radioimmunoassay Kit Ref K823379
Regimes: 510(k) Registry: 510(k)125-I Lh Radioimmunoassay Kit Ref K823380
Regimes: 510(k) Registry: 510(k)Clinetics Pca Column Ref K801306
Regimes: 510(k) Registry: 510(k)Modified Cotropin Radioimmunoassay Kit Ref K862180
Regimes: 510(k) Registry: 510(k)Cotropin Stimulataneous 57 Co-Lh 125I I-Fsh Ref K844066
Regimes: 510(k) Registry: 510(k)Radioimmunoassay Immunoglobulins D.e Ref K830357
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Clinetics Corp. have in the registry?
The registry currently lists 9 devices for Clinetics Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Clinetics Corp.'s devices?
Among its 9 most recently registered devices, Clinetics Corp. has devices listed in FDA 510(k) (9 devices).
What risk classes do Clinetics Corp.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Clinetics Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Clinetics Corp. in the registry?
The most recently registered devices listed for Clinetics Corp. include HCG BETA RIA KIT, TSH RECEPTOR ANTIBODY KIT 125I TSH, ADRENOCORTICOTROPIC HORMONE TEST and 125-I FSH RADIOIMMUNOASSAY KIT.