Primary Device ID | 10810143620051 |
NIH Device Record Key | b40a3002-5584-44bb-9ac8-5a90839cd0ce |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GenaCheck 5-Drug Rapid Self-Test Kit |
Version Model Number | RA9-E02105 |
Company DUNS | 118586095 |
Company Name | Genabio Diagnostics Inc. |
Device Count | 5 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
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 | true |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810143620054 [Primary] |
GS1 | 10810143620051 [Unit of Use] |
DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-10-16 |
Device Publish Date | 2023-10-06 |
00810143620344 - GenaCheck® COVID-19/Flu A&B Rapid Self-Test | 2025-05-27 GenaCheck® COVID-19/Flu A&B Rapid Self-Test 2T |
00810143620368 - GenaCheck® COVID-19/Flu A&B Rapid Self-Test | 2025-05-27 GenaCheck® COVID-19/Flu A&B Rapid Self-Test 4T |
00810143620214 - GenaCheck® FSH At-Home Menopause Test | 2025-03-06 |
00810143620221 - GenaCheck® Early Result Pregnancy Test | 2025-03-06 |
00810143620115 - GenaCheck® Nitrile Powder Free Examination Glove | 2025-01-21 |
00810143620139 - GenaCheck® Nitrile Powder Free Examination Glove | 2025-01-21 |
00810143620146 - GenaCheck® Nitrile Powder Free Examination Glove | 2025-01-21 |
00810143620153 - GenaCheck® Nitrile Powder Free Examination Glove | 2025-01-21 |