| Primary Device ID | B379DNS111 |
| NIH Device Record Key | 35583ee1-9eef-425e-9494-5f4dc46a6e68 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DENV Detect NS1 ELISA |
| Version Model Number | DNS1-1 |
| Catalog Number | DNS1-1 |
| Company DUNS | 004006628 |
| Company Name | INBIOS INTERNATIONAL, INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B379DNS111 [Primary] |
| QCU | Dengue Virus Antigen Assay |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-25 |
| Device Publish Date | 2018-09-24 |
| B379COVAF201 - SCoV-2 Ag Detect™ Rapid Test | 2024-09-23 POC COVID-19 antigen test, 20 tests/kit |
| B379COVAF501 - SCoV-2 Ag Detect™ Rapid Test | 2024-09-23 POC COVID-19 antigen test, 50tests/kit |
| B379STNG11 - Strongy DetectTM IgG ELISA | 2024-09-23 |
| B379AAP11 - Active Anthrax Detect Plus Rapid Test | 2023-03-13 |
| B379COV2E0 - Smart DetectTM SARS-CoV-2 rRT-PCR Kit | 2020-07-23 EUA |
| B379ZKM21 - ZIKV Detect™ 2.0 IgM Capture ELISA | 2019-06-03 |
| B379CL0251 - CL Detect Rapid Test for Cutaneous Leishmaniasis | 2018-10-25 |
| B379CP0501 - Chagas Detect™ Plus Rapid Test | 2018-10-25 |