OSUClass II
Dengue Serological Reagents
21 CFR 866.3945 / Microbiology
OSU is the FDA product code for Dengue Serological Reagents, a class II device type, regulated under 21 CFR 866.3945. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OSU
- Device name
- Dengue Serological Reagents
- FDA 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.
- Regulation
- 21 CFR 866.3945
- Device class
- Class II
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code OSU
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2011 | 1 |
Applicants with the most clearances
Product code OSU| Applicant | Clearances |
|---|---|
| Inbios Intl., Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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