Primary Device ID | B379COV2E0 |
NIH Device Record Key | 03a9877d-4b9b-486b-b4ba-74490a3919c7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Smart DetectTM SARS-CoV-2 rRT-PCR Kit |
Version Model Number | COV2-E |
Company DUNS | 004006628 |
Company Name | INBIOS INTERNATIONAL, INC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B379COV2E0 [Primary] |
QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-07-23 |
Device Publish Date | 2020-07-15 |
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 | 2020-07-23EUA |
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 |