FDA product code QCU: Dengue Virus Antigen Assay
QCU is the FDA product code for dengue virus antigen assay. It is a Class II device, regulated under 21 CFR 866.3945 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under QCU. The average 510(k) review took 84 days (median 84).
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
Classification
| Field | Value |
|---|---|
| Device name | Dengue Virus Antigen Assay |
| Device class | Class II |
| Regulation | 21 CFR 866.3945 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QCU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 84 |
Compare with all 510(k) review times · Search every QCU clearance
Top QCU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| InBios International, Inc. | 1 | 2018-08-27 |
Most recent QCU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K181473 | InBios International, Inc. | DENV Detect NS1 ELISA | 2018-08-27 | 84 |
Recalls for QCU devices
openFDA lists no recalls for product code QCU.
Frequently asked questions
What is FDA product code QCU?
QCU is the FDA product code for dengue virus antigen assay. It is a Class II device, regulated under 21 CFR 866.3945 and reviewed by the Microbiology panel.
What device class is QCU?
Class II, regulation 21 CFR 866.3945. Typical premarket route: 510(k).
How long does a 510(k) take for product code QCU?
Across 1 cleared submissions the average was 84 days from receipt to decision (median 84).
Which companies have the most QCU clearances?
InBios International, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QCU
- Run a recall and safety report across every QCU manufacturer
- Watch product code QCU for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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