| Primary Device ID | B379ZKM21 |
| NIH Device Record Key | 4a9c5081-d188-4579-846f-f7b2b26f2dba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZIKV Detect™ 2.0 IgM Capture ELISA |
| Version Model Number | IVD |
| 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 | B379ZKM21 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-03 |
| Device Publish Date | 2019-05-24 |
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| B379COV2E0 - Smart DetectTM SARS-CoV-2 rRT-PCR Kit | 2020-07-23 EUA |
| B379ZKM21 - ZIKV Detect™ 2.0 IgM Capture ELISA | 2019-06-03 |
| 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 |