GenaCheck® COVID-19/Flu A&B Rapid Self-Test

GUDID 00810143620368

GenaCheck® COVID-19/Flu A&B Rapid Self-Test 4T

Genabio Diagnostics Inc.

Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing
Primary Device ID00810143620368
NIH Device Record Key6bd2cec8-a5bc-46d9-9493-76cc2b16a0ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameGenaCheck® COVID-19/Flu A&B Rapid Self-Test
Version Model NumberRA9-E02404
Company DUNS118586095
Company NameGenabio Diagnostics Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100810143620368 [Primary]

FDA Product Code

SCAMulti-Analyte Respiratory Virus Antigen Detection Test

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-27
Device Publish Date2025-05-19

On-Brand Devices [GenaCheck® COVID-19/Flu A&B Rapid Self-Test]

00810143620368GenaCheck® COVID-19/Flu A&B Rapid Self-Test 4T
00810143620344GenaCheck® COVID-19/Flu A&B Rapid Self-Test 2T

Trademark Results [GenaCheck]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GENACHECK
GENACHECK
97927680 not registered Live/Pending
Genabio Diagnostics Inc.
2023-05-09

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