MWA — System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex Class II
Classification Details
- Product Code
- MWA
- Device Class
- Class II
- Regulation Number
- 866.3372
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.