Dengue Virus Antigen Assay
The Dengue Virus Antigen Assay is an in vitro diagnostic device for the qualitative detection of Dengue virus antigen in human serum or plasma collected from patients with signs and symptoms consistent with Dengue virus infection. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is QCU under regulation 866.3945 in the Microbiology specialty. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QCU
- Device Class
- FDA class 2
- Regulation Number
- 866.3945
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
Qualitative detection of Dengue virus antigen in human serum or plasma collected from human patients with signs and symptoms consistent with Dengue virus infection
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K181473 | DENV Detect NS1 ELISA | Aug 27, 2018 | Substantially Equivalent | InBios International, Inc. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.