510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MWAClass II

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

21 CFR 866.3372 / Microbiology
FDA source (opens on fda.gov)

MWA is the FDA product code for System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex, a class II device type, regulated under 21 CFR 866.3372. FDA's definition for this code reads: "intended to detect Mycobacterium tuberculosis complex nucleic acids extracted from human respiratory specimens. These devices are non-multiplexed and intended to be used as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings". As of , FDA records hold no 510(k) clearances under this code and 2 recalls.

Classification record

Product code
MWA
Device name
System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
FDA definition
intended to detect Mycobacterium tuberculosis complex nucleic acids extracted from human respiratory specimens. These devices are non-multiplexed and intended to be used as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings.
Regulation
21 CFR 866.3372
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
2

Companies listing this code with FDA

Companies whose registered establishments list this code