21 CFR 866.3330 — Antisera, Neutralization, Influenza Virus A, B, C
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3330
Identification
Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.
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 |
|---|---|---|---|---|
| GNR | Antisera, Neutralization, Influenza Virus A, B, C | 1 | 1 | |
| GNS | Antisera, Hai, Influenza Virus A, B, C | 1 | 9 | |
| GNT | Antigens, Ha (Including Ha Control), Influenza Virus A, B, C | 1 | 5 | |
| GNW | Antisera, Cf, Influenza Virus A, B, C | 1 | 16 | |
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | 1 | 18 | |
| NIA | Assay, Direct, Nucleic Acid Amplification, Influenza Virus | 1 | 0 | 3rd Party |
