10,000 results · 132ms · Sources: EU EUDAMED, US FDA

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

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

MTD Rapid Test Kit (Colloidal gold method)

Device
EU IVDD · Eu Ivd General ·Nanjing Synthgene Medical Technology Co., Ltd. ·On the market

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

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

FDA Pre-Market Approval
AMPLIFED MYCOBACTERIUM TUBERCULOSIS DIRECTOR (MTD) 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 ·AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST

ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

RTCII 1st gen.

FDA UDI
AMERICAN BIO MEDICA CORPORATION·10694644200352·10RapToxCup2/PPX, MTD op3 SVT

CS 2100

FDA UDI
CARESTREAM HEALTH, INC.·60889975154350·CS 2100 110V CEILING MTD

CS 2100

FDA UDI
CARESTREAM HEALTH, INC.·60889975154329·CS 2200 110V CEILING MTD

Rapid TOX

FDA UDI
AMERICAN BIO MEDICA CORPORATION·10694644100249·9RapTOX/8X + MTD Opi 2000

Wondfo Drug Test Dip Card

FDA UDI
WONDFO USA CO., LTD.·00816862020489·1-Panel Card; MTD Methadone

Wondfo Drug Test Dip Card

FDA UDI
WONDFO USA CO., LTD.·00816862025484·1-Panel Card; MTD Methadone

RTCII 1st gen.

FDA UDI
AMERICAN BIO MEDICA CORPORATION·10694644200345·10RapToxCup2/PPX, MTD opi 300

iScreen™

FDA UDI
Instant Technologies, Inc.·00817405022298·iScreen MTD Panel(Urine) 25T

DrugCheck

FDA UDI
EXPRESS DIAGNOSTICS INT'L, INC.·B298301000·Single Dip Drug Test, MTD

Isomedix Operations, Inc.

FDA registration
Isomedix Operations, Inc.·2 products·🇺🇸 United States

PENTARAY® NAV ECO High Density Mapping Catheter

FDA registration
BIOSENSE WEBSTER, INC.·2 products·🇲🇽 Mexico

Advisor HD Grid Mapping Catheter, Sensor Enabled

FDA registration
MIDWEST STERILIZATION CORP.·2 products·🇺🇸 United States

Advisor HD Grid Mapping Catheter, Sensor Enabled

FDA registration
Abbott Medical Costa Rica Ltda.·2 products·🇨🇷 Costa Rica