QuickProfile™ Covid-19/FluA&B Antigen Combo Test 71118-1T

GUDID 00855636003808

The QuickProfile Covid-19/Influenza A&B Antigen Combo Test is a lateral flow immunoassay intended for the qualitative and differential detection of nucleocapsid protein from SARS-CoV-2, influenza A and influenza B proteins using self-collected anterior nares nasal swab samples from individuals aged 14 years or older. This test is authorized for non-prescription home use with self-collected anterior nares nasal swab samples from individuals aged 14 years or older with symptoms of SARS-CoV-2, influenza A and influenza B within the first 6 days of symptom onset. This test is also authorized for non-prescription home use with adult-collected anterior nasal swab samples from individuals aged 2 years or older with symptoms of SARS-CoV-2, influenza A and influenza B within the first 6 days of symptom onset.

LUMIQUICK DIAGNOSTICS, INC.

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Primary Device ID00855636003808
NIH Device Record Key5580ae29-4238-4318-9912-9415264590f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuickProfile™ Covid-19/FluA&B Antigen Combo Test
Version Model Number71118-1T
Catalog Number71118-1T
Company DUNS790175165
Company NameLUMIQUICK DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone4088550061
Emailinfo@lumiquick.com
Phone4088550061
Emailinfo@lumiquick.com
Phone4088550061
Emailinfo@lumiquick.com
Phone4088550061
Emailinfo@lumiquick.com
Phone4088550061
Emailinfo@lumiquick.com
Phone4088550061
Emailinfo@lumiquick.com
Phone4088550061
Emailinfo@lumiquick.com
Phone4088550061
Emailinfo@lumiquick.com
Phone4088550061
Emailinfo@lumiquick.com
Phone4088550061
Emailinfo@lumiquick.com
Phone4088550061
Emailinfo@lumiquick.com
Phone4088550061
Emailinfo@lumiquick.com
Phone4088550061
Emailinfo@lumiquick.com
Phone4088550061
Emailinfo@lumiquick.com
Phone4088550061
Emailinfo@lumiquick.com
Phone4088550061
Emailinfo@lumiquick.com
Phone4088550061
Emailinfo@lumiquick.com
Phone4088550061
Emailinfo@lumiquick.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100855636003808 [Primary]
GS100855636003815 [Package]
Package: KIT [2 Units]
In Commercial Distribution
GS100855636003822 [Package]
Package: KIT [4 Units]
In Commercial Distribution
GS100855636003839 [Package]
Package: KIT [5 Units]
In Commercial Distribution
GS100855636003846 [Package]
Package: KIT [8 Units]
In Commercial Distribution
GS100855636003853 [Package]
Package: KIT [20 Units]
In Commercial Distribution

FDA Product Code

QKPCoronavirus Antigen Detection Test System.

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-11
Device Publish Date2023-09-01

Devices Manufactured by LUMIQUICK DIAGNOSTICS, INC.

00855636003808 - QuickProfile™ Covid-19/FluA&B Antigen Combo Test2023-09-11The QuickProfile Covid-19/Influenza A&B Antigen Combo Test is a lateral flow immunoassay intended for the qualitative and differential detection of nucleocapsid protein from SARS-CoV-2, influenza A and influenza B proteins using self-collected anterior nares nasal swab samples from individuals aged 14 years or older. This test is authorized for non-prescription home use with self-collected anterior nares nasal swab samples from individuals aged 14 years or older with symptoms of SARS-CoV-2, influenza A and influenza B within the first 6 days of symptom onset. This test is also authorized for non-prescription home use with adult-collected anterior nasal swab samples from individuals aged 2 years or older with symptoms of SARS-CoV-2, influenza A and influenza B within the first 6 days of symptom onset.
00855636003808 - QuickProfile™ Covid-19/FluA&B Antigen Combo Test2023-09-11 The QuickProfile Covid-19/Influenza A&B Antigen Combo Test is a lateral flow immunoassay intended for the qualitative and differ
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M90171108B1 - QuickProfile™ 2019-nCoV IgG/IgM Antibody Test2022-06-10 QuickProfile™ 2019-nCoV IgG/IgM Test Card is an immunochromatography based one step in vitro test. It is designed for the rapi
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