System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
A Mycobacterium Tuberculosis Complex Nucleic Acid Amplification System is an in vitro diagnostic device that uses nucleic acid amplification (such as PCR) to detect Mycobacterium tuberculosis complex DNA or RNA extracted from human respiratory specimens, used as an aid in the rapid diagnosis of pulmonary tuberculosis. It is FDA Class 2, requiring 510(k) clearance, with product code MWA under 21 CFR 866.3372 in the Microbiology specialty. These non-multiplexed devices are not implants and are not life-sustaining.
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Basic Information
- Product Code
- MWA
- Device Class
- FDA class 2
- Regulation Number
- 866.3372
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.