FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DENV Detect NS1 ELISA
K Number: K181473
·
Decision Aug 27, 2018
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
0
Applicant Total
7
Review Days
84
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Basic Information
- Device Name
- DENV Detect NS1 ELISA
- K Number
- K181473
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3945
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- InBios International, Inc.
- Date Received
- June 4, 2018
- Decision Date
- August 27, 2018
- Product Code
- QCU
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QCU | Dengue Virus Antigen Assay | FDA class 2 | Microbiology |
Other Clearances by InBios International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251595 | COVID-19 Detect Rapid Self -Test | Oct 12, 2025 | Substantially Equivalent |
| K233358 | SCoV-2 Ag Detect Rapid Test | Aug 23, 2024 | Substantially Equivalent |
| DEN220044 | Active Anthrax DetectTM Plus Rapid Test | Feb 3, 2023 | Unknown |
| DEN180069 | ZIKV Detect 2.0 IgM Capture ELISA | May 23, 2019 | Unknown |
| K161947 | Chagas Detect Plus Rapid Test | Dec 16, 2016 | Substantially Equivalent |
| K141341 | CL DETECT RAPID TEST | Nov 14, 2014 | Substantially Equivalent |