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XPERT CT/NG

FDA 510(k)
FDA Class 2 ·Microbiology

cobas CT/NG for use on cobas 6800/8800 systems

FDA 510(k)
FDA Class 2 ·Microbiology

HYBRID CAPTURE II CT/GC TEST

FDA 510(k)
FDA Class 2 ·Microbiology

TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY

FDA 510(k)
FDA Class 2 ·Microbiology

COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

FDA 510(k)
FDA Class 2 ·Microbiology

TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS

FDA 510(k)
FDA Class 2 ·Microbiology

GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM

FDA 510(k)
FDA Class 2 ·Microbiology

BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY

FDA 510(k)
FDA Class 2 ·Microbiology

BD MAX Check-Points CPO

FDA UDI
Check-Points Health B.V.·00180002781029·BD MAX Check-Points CPO contains: 24 each, Mast...

Alethia™ Mycoplasma Direct External Control Kit

FDA UDI
MERIDIAN BIOSCIENCE, INC.·00840733102103·The Alethia Mycoplasma Direct External Control ...

Alethia™ Mycoplasma Direct

FDA UDI
MERIDIAN BIOSCIENCE, INC.·00840733102189·The Alethia Mycoplasma Direct DNA amplification...

illumigene Mycoplasma

FDA UDI
MERIDIAN BIOSCIENCE, INC.·00840733101175·"The illumigene Mycoplasma DNA amplification as...

illumigene Mycoplasma External Control Kit

FDA UDI
MERIDIAN BIOSCIENCE, INC.·00840733101144·The illumigene Mycoplasma External Control Kit ...

Vysis

FDA UDI
ABBOTT MOLECULAR INC.·00884999036406·Vysis D7S486/CEP 7 FISH Probe Kit

illumigene Mycoplasma Direct External Control Kit

FDA UDI
MERIDIAN BIOSCIENCE, INC.·00840733101281·The illumigene Mycoplasma Direct External Contr...

illumigene Mycoplasma Direct

FDA UDI
MERIDIAN BIOSCIENCE, INC.·00840733101274·The illumigene Mycoplasma Direct DNA amplificat...

Bordetella Direct Test

FDA UDI
GREAT BASIN SCIENTIFIC, INC.·B178GBBORD100·Bordetella Direct Test Cartridge

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA Pre-Market Approval
FDA Class 3 ·Vysis CLL FISH Probe Kit

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval
FDA Class 3 ·Vysis ALK Break Apart FISH Probe Kit

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval
FDA Class 3 ·DAKOCYTOMATION HER2 FISH PHARMDX KIT