BD VIPER LT SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Revogene

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Revogene

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

3M INTEGRATED CYCLER (110V) & (220V)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARIES System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARIES System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

revogene

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Assay For Detection Of Proteases In Chronic Wounds

FDA classification

FDA Class 2 ·Assay For Detection Of Proteases In Chronic Wounds

Cell Enzymes (Erythrocytic And Leukocytic)

FDA classification

FDA Class 2 ·Cell Enzymes (Erythrocytic And Leukocytic)

MINI S.F.T. (URINE PRESERVATIVE)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MAGNET PAD

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

FDA classification

FDA Class 2 ·Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA classification

FDA Class 3 ·System, Test, Tumor Marker, For Detection Of Bladder Cancer

System, Test, Tumor Marker, Monitoring, Bladder

FDA classification

FDA Class 2 ·System, Test, Tumor Marker, Monitoring, Bladder

Kit, Direct Antigen, Positive Control

FDA classification

FDA Class 1 ·Kit, Direct Antigen, Positive Control