101 results · 43ms · Sources: EU EUDAMED, US FDA

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval
FDA Class 2 ·AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval
FDA Class 2 ·AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval
FDA Class 2 ·GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval
FDA Class 2 ·AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval
FDA Class 2 ·AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval
FDA Class 2 ·GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval
FDA Class 2 ·AMPLICOR (TM) MYCOBACTERIUM TUBERCULOSIS TEST

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval
FDA Class 2 ·GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval
FDA Class 2 ·GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA classification
FDA Class 2 ·System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

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

OQW / 2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identification

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

Tuberculosis (TB) Rapid Test Dipstick

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

AV Avantage™ A/H5N1 Flu Test

FDA registration
ARBOR VITA CORPORATION·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

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

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

MYCOBACTERIUM PCR

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

ACCUPROBE®

FDA UDI
Hologic, Inc.·15420045506145·AccuProbe® Mycobacterium gordonae.