Dengue Serological Reagents
The Dengue Serological Reagents (product code OSU) are in vitro diagnostic devices consisting of antigens and antisera for the detection of anti-dengue antibodies in individuals with signs and symptoms consistent with dengue infection. The test aids in the presumptive clinical laboratory diagnosis of dengue fever or dengue hemorrhagic fever caused by dengue virus, in conjunction with other clinical and laboratory findings. As an FDA Class 2 device under regulation 866.3945, it requires 510(k) premarket clearance and falls within the Microbiology specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OSU
- Device Class
- FDA class 2
- Regulation Number
- 866.3945
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
Dengue virus serological reagents are devices that consist of antigens and antisera for the detection of anti-dengue antibodies, individuals that have signs and symptoms consistent with dengue. The detection aids in the clinical laboratory diagnosis of dengue fever or dengue hemorrhagic fever caused by dengue virus. The device is intended for use in the presumptive diagnosis of patients in conjunction with other clinical and laboratory findings.
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 |
|---|---|---|---|---|
| DEN100020 | DENV DETECT IGM CAPTURE ELISA | Apr 08, 2011 | Unknown | Inbios Intl., Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.