HealthConfirm

GUDID 00850041721118

HealthConfirm Covid/ Flu Combo Test

CONFIRM BIOSCIENCES, INC.

Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing
Primary Device ID00850041721118
NIH Device Record Keyc332f966-406d-4fc7-acf6-a24a9866f252
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealthConfirm
Version Model NumberCB-HC-Cassette-Covid Flu A/B (OTC)
Company DUNS806524968
Company NameCONFIRM BIOSCIENCES, 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 Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-908-5603
Emailcs@confirmbiosciences.com
Phone1-800-908-5603
Emailcs@confirmbiosciences.com
Phone1-800-908-5603
Emailcs@confirmbiosciences.com
Phone1-800-908-5603
Emailcs@confirmbiosciences.com
Phone1-800-908-5603
Emailcs@confirmbiosciences.com
Phone1-800-908-5603
Emailcs@confirmbiosciences.com
Phone1-800-908-5603
Emailcs@confirmbiosciences.com
Phone1-800-908-5603
Emailcs@confirmbiosciences.com
Phone1-800-908-5603
Emailcs@confirmbiosciences.com
Phone1-800-908-5603
Emailcs@confirmbiosciences.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850041721118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2025-09-22
Device Publish Date2025-09-12

On-Brand Devices [HealthConfirm]

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

Trademark Results [HealthConfirm]

Mark Image

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

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