Placental Alpha Microglobulin-1 Immunoassay
Device Code: 6301
Product Code(s):
QBB Definition: A Placental Alpha Microglobulin-1 Immunoassay Is A Qualitative Test Intended To Detect The Presence Of Placental Alpha Microglobulin 1 (PAMG-1) In Cervicovaginal Secretions. The Test Is Indicated As An Aid To Assess The Risk Of Spontaneous Preterm De
Device Classification Information
| Device Type ID | 6301 |
| Device Name | Placental Alpha Microglobulin-1 Immunoassay |
| Physical State | In Vitro Diagnostic Test |
| Technical Method | Qualitative Immunochromatographic Test |
| Target Area | Cervicovaginal Secretions |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | QBB |
| 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 | 6301 |
| Device | Placental Alpha Microglobulin-1 Immunoassay |
| Product Code | QBB |
| FDA Device Classification | Class 3 Medical Device |
TPLC Last Update: 2019-04-02 21:20:04