LAB-TEK JEMBEC G.C. CULTURE SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM

FDA 510(k)

FDA Class 2 ·Microbiology

Access sTfR

FDA 510(k)

FDA Class 2 ·Immunology

Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack

FDA 510(k)

FDA Class 2 ·Microbiology

LYME STAT M TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

DAB DETECTION KIT

FDA 510(k)

FDA Class 2 ·Immunology

Aptima SARS-CoV-2 Assay

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 AST-ST TIGECYCLINE

FDA 510(k)

FDA Class 2 ·Microbiology

HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)

FDA 510(k)

FDA Class 2 ·Immunology

MYOGLOBIN FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Immunology

QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-N DNA ANTIBODY TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

DAPTOMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

MALDI Biotyper CA (MBT-CA) System, MBT smart CA System

FDA 510(k)

FDA Class 2 ·Microbiology

SM ANTIBODY TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

HEMAGEN ENA [JO-1] KIT (EIA METHOD)

FDA 510(k)

FDA Class 2 ·Immunology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS

FDA 510(k)

FDA Class 2 ·Microbiology

cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems

FDA 510(k)

FDA Class 2 ·Microbiology

JUSTONE

FDA 510(k)

FDA Class 2 ·Microbiology