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.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue64

Newest first, rows 51-64 of 64

Search and filter all 64 devices

Tandem-M Immunoenzymetric Assay For Ige-- Ref K863858

Active Regimes: 510(k) Registry: 510(k) Class:II
Tandem Pap Kit - (Parts I & Ii) Ref K811959

Active Regimes: 510(k) Registry: 510(k) Class:II
Tandemr Iconr Ii Hcg(Serum) Immunoenzymetric Assay Ref K865057

Active Regimes: 510(k) Registry: 510(k) Class:II
Tandem-R Ostase Immunoradiometric Assay Ref K930810

Active Regimes: 510(k) Registry: 510(k) Class:II
Tandem-Mp Ostase Immunoenzymetric Assay Ref K972666

Active Regimes: 510(k) Registry: 510(k) Class:II
Tandem Qualitative Hcg Kit Ref K812461

Active Regimes: 510(k) Registry: 510(k) Class:II
Encore Ferritin Reagent Ref K850680

Active Regimes: 510(k) Registry: 510(k) Class:II
Tandem Icon Rubella Igg Immunoenzymetric Assay Kit Ref K853069

Active Regimes: 510(k) Registry: 510(k) Class:II
Hybritech Data Station Ref K834300

Active Regimes: 510(k) Registry: 510(k) Class:I
Icon Reader Ref K862956

Active Regimes: 510(k) Registry: 510(k) Class:I
Tandem - Hgh Kit Ref K821366

Active Regimes: 510(k) Registry: 510(k) Class:I
Tandem-E Tsh Calibration Verification Control Set Ref K912439

Active Regimes: 510(k) Registry: 510(k) Class:I
Tandem R-Total B-Gcg Kit Ref K833194

Active Regimes: 510(k) Registry: 510(k) Class:II
Tandem(R)-R Carcinoembryonic Antigen Assay Ref P840019

Active Regimes: PMA Registry: PMA Class:II

Rows 51-64 of 64

Showing 51-64 of 64

What Hybritech, Inc. makes

Catalogue64

Tandem-M Immunoenzymetric Assay For Ige-- Ref K863858

Tandem Pap Kit - (Parts I & Ii) Ref K811959

Tandemr Iconr Ii Hcg(Serum) Immunoenzymetric Assay Ref K865057

Tandem-R Ostase Immunoradiometric Assay Ref K930810

Tandem-Mp Ostase Immunoenzymetric Assay Ref K972666

Tandem Qualitative Hcg Kit Ref K812461

Encore Ferritin Reagent Ref K850680

Tandem Icon Rubella Igg Immunoenzymetric Assay Kit Ref K853069

Hybritech Data Station Ref K834300

Icon Reader Ref K862956

Tandem - Hgh Kit Ref K821366

Tandem-E Tsh Calibration Verification Control Set Ref K912439

Tandem R-Total B-Gcg Kit Ref K833194

Tandem(R)-R Carcinoembryonic Antigen Assay Ref P840019