21 CFR 866.3400 — Antisera, Neutralization, Parainfluenza Virus 1-4
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3400
Identification
Parainfluenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to parainfluenza virus in serum. The identification aids in the diagnosis of parainfluenza virus infections and provides epidemiological information on diseases caused by these viruses. Parainfluenza viruses cause a variety of respiratory illnesses ranging from the common cold to pneumonia.
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 |
|---|---|---|---|---|
| GQP | Antisera, Neutralization, Parainfluenza Virus 1-4 | 1 | 2 | |
| GQQ | Antisera, Hai, Parainfluenza Virus 1-4 | 1 | 1 | |
| GQR | Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4 | 1 | 1 | |
| GQS | Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 | 1 | 11 | |
| GQT | Antisera, Cf, Parainfluenza Virus 1-4 | 1 | 4 | |
| NHZ | Assay, Direct, Nucleic Acid Amplification, Parainfluenza Virus | 1 | 0 | 3rd Party |
