FREELITE LAMBDA FREE KIT

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA Centaur HAV IgM Assay

FDA 510(k)

FDA Class 2 ·Microbiology

Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2

FDA 510(k)

FDA Class 2 ·Microbiology

OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test

FDA 510(k)

FDA Class 2 ·Immunology

Selux AST System; Model AST Gen 1.0

FDA 510(k)

FDA Class 2 ·Microbiology

INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)

FDA 510(k)

FDA Class 2 ·Microbiology

K-ASSAY IGA

FDA 510(k)

FDA Class 2 ·Immunology

FITC GOAT ANTI-HUMAN IGM H CHAIN

FDA 510(k)

FDA Class 2 ·Immunology

CPR SLIDE EIKEN

FDA 510(k)

FDA Class 2 ·Immunology

STRATUS MYOGLOBIN FLUOROMETRIC ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020

FDA 510(k)

FDA Class 2 ·Microbiology

DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH

FDA 510(k)

FDA Class 2 ·Immunology

HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD)

FDA 510(k)

FDA Class 2 ·Immunology

cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System

FDA 510(k)

FDA Class 2 ·Microbiology

revogene

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

ARIES MRSA Assay

FDA 510(k)

FDA Class 2 ·Microbiology

IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)

FDA 510(k)

FDA Class 2 ·Immunology

QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACK

FDA 510(k)

FDA Class 2 ·Immunology

SAS SALMONELLA H G,M,Q ANTISERMU

FDA 510(k)

FDA Class 2 ·Microbiology