Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria
Device Code: 3617
Product Code(s):
OJO Definition: Enzyme Linked Immunosorbent Assay (elisa) System Intended For In Vitro Diagnostic Use To Qualitatively Detect The Presence Of Lipoarabinomannan (lam) Antigen Of Mycobacteria In Human Urine As An Aid In The Diagnosis Of Current Mycobacterial Infection
Device Classification Information
| Device Type ID | 3617 |
| Device Name | Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria |
| Physical State | In Vitro |
| Technical Method | In Vitro |
| Target Area | In Vitro |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | Contact ODE |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | OJO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3617 |
| Device | Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria |
| Product Code | OJO |
TPLC Last Update: 2019-04-02 20:33:16