PCL · Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
Microbiology · 21 CFR 866.3520 · Class 1
Overview
| Product Code | PCL |
|---|---|
| Device Name | Enzyme Linked Immunoabsorbent Assay, Rubeola Igm |
| Regulation | 21 CFR 866.3520 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
Rubeola (measles) virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubeola virus in serum. The identification aids in the diagnosis of measles and provides epidemiological information on the disease. Measles is an acute, highly infectious disease of the respiratory and reticuloendothelial tissues, particularly in children, characterized by a confluent and blotchy rash.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K140455 | CAPTIA MEASLES IGM | Trinity Biotech USA | May 22, 2014 | SESE |
Top Applicants
- Trinity Biotech USA — 1 clearance
