Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-linked Immunospot Test
Device Code: 3616
Product Code(s):
OJN Definition: For The Detection Of Effector T Cells That Respond To Stimulation By Mycobacterium Tuberculosis Antigens ESAT-6 And CFP-10 And Indicated For Use As An Aid In The Diagnosis Of M. Tuberculosis Infection In Conjunction With Risk Assesment, Radiography A
Device Classification Information
| Device Type ID | 3616 |
| Device Name | Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-linked Immunospot Test |
| Physical State | In Vitro Diagnostic Kit |
| Technical Method | Enzyme-linked Immunospot Assay |
| Target Area | Peripheral Blood |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OJN |
| 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 | 3616 |
| Device | Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-linked Immunospot Test |
| Product Code | OJN |
| FDA Device Classification | Class 3 Medical Device |
TPLC Last Update: 2019-04-02 20:33:15