Rapid SARS-CoV-2 Antigen Test Card 1N40C5-1-US-BS

GUDID 00855636003723

The Rapid SARS-CoV-2 Antigen Test Card is a single use rapid lateral flow chromatographic immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 and older, when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19. This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years and older when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized for individuals aged 2 years and older with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.

LUMIQUICK DIAGNOSTICS, INC.

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Primary Device ID00855636003723
NIH Device Record Keyfad87d12-433c-46aa-a16f-606d478d28f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameRapid SARS-CoV-2 Antigen Test Card
Version Model Number1N40C5-1-US-BS
Catalog Number1N40C5-1-US-BS
Company DUNS790175165
Company NameLUMIQUICK DIAGNOSTICS, INC.
Device Count1
DM Exempttrue
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 Perscriptionfalse
OTC Over-The-Countertrue

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
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
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
GS100855636003716 [Primary]
GS100855636003723 [Package]
Contains: 00855636003716
Package: Kit [2 Units]
In Commercial Distribution
GS100855636003730 [Package]
Contains: 00855636003716
Package: Kit [4 Units]
In Commercial Distribution
GS100855636003747 [Package]
Contains: 00855636003716
Package: Kit [5 Units]
In Commercial Distribution
GS100855636003754 [Package]
Contains: 00855636003716
Package: Kit [8 Units]
In Commercial Distribution
GS100855636003761 [Package]
Contains: 00855636003716
Package: Kit [10 Units]
In Commercial Distribution
GS100855636003778 [Package]
Contains: 00855636003716
Package: Kit [20 Units]
In Commercial Distribution
GS100855636003785 [Package]
Contains: 00855636003716
Package: Kit [40 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 Date2022-04-20
Device Publish Date2022-04-12

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