IAFP MUELLER HINTON AGAR

FDA 510(k)

FDA Class 2 ·Microbiology

COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV

FDA 510(k)

FDA Class 2 ·Microbiology

Sensititre Susceptibility Plates

FDA 510(k)

FDA Class 2 ·Microbiology

Alinity i Toxo IgM

FDA 510(k)

FDA Class 2 ·Microbiology

ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System

FDA 510(k)

FDA Class 2 ·Microbiology

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit

FDA 510(k)

FDA Class 2 ·Microbiology

ACCESS RUBELLA IGG

FDA 510(k)

FDA Class 2 ·Microbiology

TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I)

FDA 510(k)

FDA Class 2 ·Microbiology

Visby Medical Sexual Health Test

FDA 510(k)

FDA Class 2 ·Microbiology

IS-RUBELLA IGG TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN

FDA 510(k)

FDA Class 2 ·Microbiology

AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI

FDA 510(k)

FDA Class 2 ·Microbiology

CEFOTAXIME 30MCG ANTIMICROBIAL SUSCEP.

FDA 510(k)

FDA Class 2 ·Microbiology

HSV TEST

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST

FDA 510(k)

FDA Class 2 ·Microbiology

SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES

FDA 510(k)

FDA Class 2 ·Microbiology

UROPAPER EIKEN UHAG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PASCO MIC AND MIC/ID PANELS, VANCOMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

AMIZYME-TOXOPLASMA GONDII KIT

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6

FDA 510(k)

FDA Class 2 ·Microbiology