N LATEX RF KIT

FDA 510(k)

FDA Class 2 ·Immunology

SAS SHIGELLA BOYDII TYPE 10 ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

LIAISON Ferritin

FDA 510(k)

FDA Class 2 ·Immunology

AMOXICILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 – 8 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

ASI Automated ASI RPR Test for Syphilis on the ASI Evolution

FDA 510(k)

FDA Class 2 ·Microbiology

Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUANTA-MATE VITAMIN B-12/FOLATE RA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LIQUICHEK RHEUMATOID FACTOR CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

RHEUMELISA II HISTONE ANTIBODY TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

QM2/QM300 BUFFER AND DILUENT PACK

FDA 510(k)

FDA Class 2 ·Immunology

Solana Influenza A+B Assay

FDA 510(k)

FDA Class 2 ·Microbiology

BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2

FDA 510(k)

FDA Class 2 ·Microbiology

Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae)

FDA 510(k)

FDA Class 2 ·Microbiology

BIOTROL TOXO ELISA TEST M

FDA 510(k)

FDA Class 2 ·Microbiology

OLYMPUS PK TP(TM) SYSTEM, MODIFICATION

FDA 510(k)

FDA Class 2 ·Microbiology

UBI MAGIWEL RF-IGM QUANTITATIVE

FDA 510(k)

FDA Class 2 ·Immunology

SCEPTOR STREPTOCOCCUS MIC/ID PANEL #80323

FDA 510(k)

FDA Class 2 ·Microbiology