ENDAB THYROID UPTAKE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ETEST Telavancin (TLA) (0.002-32 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

ORTHO* TOXOPLASMA-G ANTIBODY ELISA TEST

FDA 510(k)

FDA Class 2 ·Microbiology

SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS

FDA 510(k)

FDA Class 2 ·Microbiology

PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

CEFUROXIME 30MCG. SUSCEP DISK

FDA 510(k)

FDA Class 2 ·Microbiology

VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO

FDA 510(k)

FDA Class 2 ·Microbiology

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)

FDA 510(k)

FDA Class 2 ·Microbiology

HARDY DISK AMPICILLIN/SULBACTAM

FDA 510(k)

FDA Class 2 ·Microbiology

SULFACYTINE 0.25 MG.

FDA 510(k)

FDA Class 2 ·Microbiology

Lyme B. burgdorferi (IgM) MarStripe Test

FDA 510(k)

FDA Class 2 ·Microbiology

Elecsys BRAHMS PCT

FDA 510(k)

FDA Class 2 ·Microbiology

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

CLEARinse CTS Specimen Collection and Transport System

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFIED N.Y.C. FERMENTATION MEDIUM BASE

FDA 510(k)

FDA Class 2 ·Microbiology

ANA LATEX SLIDE TEST

FDA 510(k)

FDA Class 2 ·Immunology

SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL

FDA 510(k)

FDA Class 2 ·Microbiology