System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
Device Code: 3500
Product Code(s):
MWA 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 Wi
Device Classification Information
| Device Type ID | 3500 |
| Device Name | System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex |
| Regulation Description | Nucleic Acid-based In Vitro Diagnostic Devices For The Detection Of Mycobacterium Tuberculosis Complex In Respiratory Specimens. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3372 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MWA |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3500 |
| Device | System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex |
| Product Code | MWA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Nucleic Acid-based In Vitro Diagnostic Devices For The Detection Of Mycobacterium Tuberculosis Complex In Respiratory Specimens. |
| CFR Regulation Number | 866.3372 [🔎] |
| Device Problems |
|---|
Incorrect Software Programming Calculations | 1 |
| Total Device Problems | 1 |
TPLC Last Update: 2019-04-02 20:31:15