Hybritech, Inc.
United StatesFDA applicant, unverified
- Devices
- 64
What Hybritech, Inc. makes
Hybritech, Inc. manufactures immunoenzymetric assay kits and related reagents for laboratory testing, including hormone assays such as human chorionic gonadotropin (HCG), luteinizing hormone (LH), thyroid-stimulating hormone (TSH), prolactin, ferritin, follicle-stimulating hormone (FSH), and papillomavirus (PAP). The company also produces calibration verification controls and immunoassay analyzers designed for automated diagnostic measurements in clinical settings.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with some products authorised via the 510(k) and PMA pathways. These products are listed in the FDA’s regulatory databases, and the company operates from the United States.
Catalogue
Search and filter all 64 devicesShowing 1-50 of 64
Frequently asked questions
How many devices does Hybritech, Inc. have in the registry?
The registry currently lists 64 devices for Hybritech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hybritech, Inc.'s devices?
Among its 50 most recently registered devices, Hybritech, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Hybritech, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Hybritech, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hybritech, Inc. in the registry?
The most recently registered devices listed for Hybritech, Inc. include TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT, TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT, TANDEM-E THYROID STIMULATING HORMONE KIT and TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY.