PCL — Enzyme Linked Immunoabsorbent Assay, Rubeola Igm Class I
FDA product code PCL covers "Enzyme Linked Immunoabsorbent Assay, Rubeola Igm", a Class I medical device regulated under 21 CFR 866.3520. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PCL
- Device Class
- Class I
- Regulation Number
- 866.3520
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
The qualitative detection of measles specific IgM antibodies in serum or plasma.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K140455 | trinity biotech usa | CAPTIA MEASLES IGM | May 22, 2014 |