QCU · Dengue Virus Antigen Assay
Microbiology · 21 CFR 866.3945 · Class 2
Overview
| Product Code | QCU |
|---|---|
| Device Name | Dengue Virus Antigen Assay |
| Regulation | 21 CFR 866.3945 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
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).
Special Controls
*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).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K181473 | DENV Detect NS1 ELISA | InBios International, Inc. | Aug 27, 2018 | SESE |
Top Applicants
- InBios International, Inc. — 1 clearance
