ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10

FDA 510(k)

FDA Class 1 ·Microbiology

IMMUNOCARD C. DIFFICILE GDH

FDA 510(k)

FDA Class 1 ·Microbiology

TRU RSV

FDA 510(k)

FDA Class 1 ·Microbiology

ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT

FDA 510(k)

FDA Class 1 ·Microbiology

TRU FLU, MODEL 751230

FDA 510(k)

FDA Class 2 ·Microbiology

IMMUNOCARDSTAT HPSA

FDA 510(k)

FDA Class 1 ·Microbiology

TRU FLU

FDA 510(k)

FDA Class 2 ·Microbiology

TRU Legionella

FDA 510(k)

FDA Class 2 ·Microbiology

Curian® Shiga Toxin

FDA 510(k)

FDA Class 1 ·Microbiology

IMMUNOCARD TOXINS A & B, MODEL 712050

FDA 510(k)

FDA Class 1 ·Microbiology

illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10

FDA 510(k)

FDA Class 2 ·Microbiology

Curian HpSA, Curian Analyzer

FDA 510(k)

FDA Class 1 ·Microbiology

ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA

FDA 510(k)

FDA Class 2 ·Microbiology

illumigene Pertussis DNA Amplification Assay

FDA 510(k)

FDA Class 2 ·Microbiology

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATHTEK UBT FOR H.PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATH TEK UBT FOR H.PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA)

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BreathTek UBT for H. pylori Kit and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA)