# P940034: Gen-Probe (R) Amplified Mycobacterium Tuberculosis Direct Test (MTD Test)

- Pathway: PMA
- Applicant: Gen-Probe, Inc.
- Decided: Dec 15, 1995 after 522 days
- Product code: MWA (System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex)
- Device class: 2
- Regulation: 21 CFR 866.3372
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

Source page: https://510kreport.com/device/P940034
Methodology: https://510kreport.com/methodology