Skip to content

Amplified Mycobacterium Tuberculosis Direct Test (MTD Test)

by Gen-Probe

PMA P940034

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P940034↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPRL NumberP940034 Date15 Dec 1995DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Gen-Probe(R) Amplified Mycobacterium Tuberculosis Direct Test (Mtd Test)
Generic Name
System, nucleic acid amplification, mycobacterium tuberculosis complex
FDA applicant
Gen-Probe, Inc.
PMA Number
FDA Product Code
MWA
Device Class
Class II
Regulation
21 CFR Part 866.3372
Advisory Committee
Microbiology
FDA Decision
APRL

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Amplified Mycobacterium Tuberculosis Direct Test (MTD Test) is a nucleic acid amplification system designed for the in vitro detection of Mycobacterium tuberculosis complex ribosomal RNA (rRNA) in clinical specimens. It functions as a molecular diagnostic tool to identify M. tuberculosis directly from acid-fast bacilli (AFB) smear-positive or negative concentrated sediments, including sputum or bronchial specimens.

This test is supplied as a single-use diagnostic device and is intended for use in microbiology laboratories. It requires amplification of target nucleic acid sequences for detection via hybridization probes, with results available more rapidly than traditional culture methods. The device is regulated under FDA Premarket Approval (PMA) and falls under Class II classification (MWA product code) for microbiology applications, adhering to strict in vitro diagnostic (IVD) standards.

Other devices from Gen-Probe

See all devices from Gen-Probe →