21 CFR 866.3945 — Dengue Serological Reagents
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3945
Identification
Dengue virus serological reagents are devices that consist of antigens and antibodies for the detection of dengue virus and dengue antibodies in individuals who have signs and symptoms of dengue fever or dengue hemorrhagic fever. The detection aids in the clinical laboratory diagnosis of dengue fever or dengue hemorrhagic fever caused by dengue virus.
Classification Rationale
Class II (special controls). The special control is FDA's guideline entitled “Class II Special Controls Guideline: Dengue Virus Serological Reagents.” For availability of the guideline document, see § 866.1(e).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| OSU | Dengue Serological Reagents | 2 | 1 | |
| QCU | Dengue Virus Antigen Assay | 2 | 1 |
Special Controls
OSU — Dengue Serological Reagents
*Classification.* Class II (special controls). The special control is FDA's guideline entitled “Class II Special Controls Guideline: Dengue Virus Serological Reagents.” For availability of the guideline document, see § 866.1(e).
eCFR
OSU — Dengue Serological Reagents
The special control is FDA's guideline entitled “Class II Special Controls Guideline: Dengue Virus Serological Reagents.” For availability of the guideline document, see § 866.1(e).
Ecfr Llm
QCU — Dengue Virus Antigen Assay
*Classification.* Class II (special controls). The special control is FDA's guideline entitled “Class II Special Controls Guideline: Dengue Virus Serological Reagents.” For availability of the guideline document, see § 866.1(e).
eCFR
