108 results · 41ms · Sources: EU EUDAMED, US FDA

Xpert MTB/RIF

FDA registration
Cepheid·1 product·🇺🇸 United States

Xpert MTB/RIF Ultra

FDA registration
Cepheid·1 product·🇺🇸 United States

Xpert MTB/RIF

FDA registration
CEPHEID·1 product·🇺🇸 United States

Xpert MTB/RIF

FDA registration
CEPHEID·1 product·🇺🇸 United States

Mycobacterium Tuberculosis Drug Resistance Panel Kit

FDA registration
CODIAGNOSTICS·1 product·🇺🇸 United States

Xpert MTB/RIF

FDA registration
Cepheid·1 product·🇺🇸 United States

Xpert MTB/RIF Ultra

FDA registration
CEPHEID·1 product·🇺🇸 United States

Xpert MTB/RIF

FDA UDI
CEPHEID·07332940000912·Xpert MTB/RIF kit; 10 test kit

XPERT MTB/RIF ASSAY

FDA 510(k)
FDA Class 2 ·Microbiology

Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80

FDA 510(k)
FDA Class 2 ·Microbiology

System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen

FDA classification
FDA Class 2 ·System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen

TB STAT PAK II

FDA registration
Chembio Diagnostic Systems·1 product·🇺🇸 United States

TUBERCULOSIS (TB) IgM ELISA

FDA registration
MONOCENT INC.·1 product·🇺🇸 United States

NDZ / ASSAY, NUCLEIC ACID AMPLIFICATION, GROWTH IDENTIFICATION, MYCOBACTERIUM TUBERCULOSIS

FDA registration
MONOCENT INC.·1 product·🇺🇸 United States

Tuberculosis (TB) Rapid Test Dipstick

FDA registration
ACRO BIOTECH Inc.·1 product·🇺🇸 United States

HEALGEN SCIENTIFIC LLC

FDA registration
HEALGEN SCIENTIFIC LLC·1 product·🇺🇸 United States

KIT CTM MTB 48T EXPT-IVD

FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States

TUBERCULOSIS (TB) IgG ELISA

FDA registration
MONOCENT INC.·1 product·🇺🇸 United States

OnSite TB IgG/IgM Combo Rapid Test (REF# R0053C)

FDA registration
CTK BIOTECH, INC.·1 product·🇺🇸 United States

BD ProbeTec DTB kit

FDA registration
BECTON, DICKINSON & CO.·1 product·🇺🇸 United States