Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application

FDA 510(k)

FDA Class 2 ·Microbiology

IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology

E. HISTOLYTICA TEST

FDA 510(k)

FDA Class 2 ·Microbiology

The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml.

FDA 510(k)

FDA Class 2 ·Microbiology

MTS Ceftobiprole 0.002-32 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE

FDA 510(k)

FDA Class 2 ·Microbiology

TROVAFLOXACIN 10G, SENSI-DISC

FDA 510(k)

FDA Class 2 ·Microbiology

MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN

FDA 510(k)

FDA Class 2 ·Microbiology

COR DOT CMV

FDA 510(k)

FDA Class 2 ·Microbiology

MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

CHROMOTITRE E.I.A. RUBELLA IGG

FDA 510(k)

FDA Class 2 ·Microbiology

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

FAS FASTIDIOUS MIC PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

BIOMERIEUX HEMOLAB AT III

FDA 510(k)

FDA Class 2 ·Hematology

SAS SALMONELLA O GROUP Z FACTOR 50 ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

GENZYME OSOM INFLUENZA A & B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

IMMUNOCOMB(TM) TOXOPLASMA IGG ANTIBODY TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

GRAM NEGATIVE COMBO PANEL TYPE 3

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01

FDA 510(k)

FDA Class 2 ·Microbiology

BIOSIGN FLU A + B, STATUS FLU A & B

FDA 510(k)

FDA Class 2 ·Microbiology