GEN-PROBE (R) LUMINOMETER - LEADER (TM)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DISPOSABLE LAPAROSCOPIC SWAB WITH REUSABLE HANDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TEFLON UTERINE SOUND

FDA 510(k)

FDA Class 1 ·Obstetrics/Gynecology

ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA.

FDA 510(k)

FDA Class 1 ·Microbiology

SHEPARD INTRAUTERINE INSEMINATION CATHETER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ACCUPROBE STAPHYLOCOCCUS AUREUS CULTURE CONFIRMA.

FDA 510(k)

FDA Class 1 ·Microbiology

GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST

FDA 510(k)

FDA Class 1 ·Microbiology

ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TEST

FDA 510(k)

FDA Class 1 ·Microbiology

ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM.

FDA 510(k)

FDA Class 2 ·Microbiology

COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

GEN-PROBE MYCOPLASMA PNEUMONIA RAPID DETECT SYSTEM

FDA 510(k)

FDA Class 1 ·Microbiology

PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS

FDA 510(k)

FDA Class 1 ·Microbiology

O2 BOOT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INTRATUBAL TRANSFER SETS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE

FDA 510(k)

FDA Class 1 ·Microbiology

ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION

FDA 510(k)

FDA Class 1 ·Microbiology

MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOM

FDA 510(k)

FDA Class 2 ·Hematology

ACCUPROBE BLASTOMYCES DERMATIT CULT CONFIRM TEST

FDA 510(k)

FDA Class 2 ·Microbiology