21 CFR 866.3520 — Antiserum, Fluorescent, Rubeola
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3520
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GRE | Antiserum, Fluorescent, Rubeola | 1 | 4 | |
| GRF | Antiserum, Cf, Rubeola | 1 | 2 | |
| GRG | Antiserum, Hai, Rubeola | 1 | 0 | |
| GRH | Antigen, Ha (Including Ha Control), Rubeola | 1 | 0 | |
| GRI | Antiserum, Neutralization, Rubeola | 1 | 0 | |
| GRJ | Antigen, Cf, (Including Cf Control), Rubeola | 1 | 2 | |
| LJB | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | 1 | 11 | |
| PCL | Enzyme Linked Immunoabsorbent Assay, Rubeola Igm | 1 | 1 |
