21 CFR 866.3395 — Norovirus Serological Reagent
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3395
Identification
Norovirus serological reagents are devices that consist of antigens and antisera used in serological tests to detect the presence of norovirus antigens in fecal samples. These devices aid in the diagnosis of norovirus infection in the setting of an individual patient with symptoms of acute gastroenteritis when the individual patient is epidemiologically linked to other patients with symptoms of acute gastroenteritis and/or aid in the identification of norovirus as the etiology of an outbreak of acute gastroenteritis in the setting of epidemiologically linked patients with symptoms of acute gastroenteritis.
Classification Rationale
Class II (special 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. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Norovirus Serological Reagents.” See § 866.1(e) for the availability of this guidance document.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| OUC | Norovirus Serological Reagent | 2 | 1 |
Special Controls
OUC — Norovirus Serological Reagent
The device is classified as Class II under regulation 21 CFR 866.3395 with special controls. The special control guidance document "Class II Special Controls Guidance Document: Immunoassay or Antigen Detection-based In Vitro Diagnostic Devices for Norovirus Detection" will be available shortly.
De Novo Order DEN110001
OUC — Norovirus Serological Reagent
*Classification.* Class II (special 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. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Norovirus Serological Reagents.” See § 866.1(e) for the availability of this guidance document.
eCFR
OUC — Norovirus Serological Reagent
The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Norovirus Serological Reagents.” See § 866.1(e) for the availability of this guidance document.
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