PCL
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3520
- Medical specialty
- Microbiology
- FDA definition
- The qualitative detection of measles specific IgM antibodies in serum or plasma.
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| Record | Firm | Date |
|---|---|---|
| CAPTIA MEASLES IGM (K140455) | Trinity Biotech USA | 2014-05-22 |
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