HealthConfirm

GUDID 20850041721129

Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing

Primary Device ID	20850041721129
NIH Device Record Key	a0c84523-1ce4-42c9-97df-19b5b7ba0c93
Commercial Distribution Status	In Commercial Distribution
Brand Name	HealthConfirm
Version Model Number	CB-HC-Cassette-Covid Flu A/B (OTC) 2PACK
Company DUNS	806524968
Company Name	CONFIRM BIOSCIENCES, 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	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	00850041721125 [Primary]
GS1	20850041721129 [Package] Contains: 00850041721125 Package: Case [30 Units] In Commercial Distribution

SCA	Multi-Analyte Respiratory Virus Antigen Detection Test

Steralize Prior To Use	false
Device Is Sterile	false

00856464008683	This test has not been FDA cleared or approved. This test has been authorized by FDA under an EU
20850041721136	HealthConfirm Covid/ Flu Combo Test 4 Pack
20850041721129	HealthConfirm Covid/ Flu Combo Test 2 Pack
00850041721118	HealthConfirm Covid/ Flu Combo Test

Mark Image Registration \| Serial	Company Trademark Application Date
HEALTHCONFIRM 87682011 5539196 Live/Registered	CONFIRM BIOSCIENCES, INC. 2017-11-13