Boson - Rapid SARS-CoV-2 Antigen Test Card - 2 Tests/Kit

GUDID 06921963712509

Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 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.

Xiamen Boson Biotech Co., Ltd.

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Primary Device ID06921963712509
NIH Device Record Key70a2e92f-71b1-498c-a4e8-6cc9c80ec6e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameBoson - Rapid SARS-CoV-2 Antigen Test Card - 2 Tests/Kit
Version Model Number1N40C5-2-US
Company DUNS527409818
Company NameXiamen Boson Biotech Co., Ltd.
Device Count2
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 Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1-800-689-7794
Emailsupport@bosoncovt.com
Phone+1-800-689-7794
Emailsupport@bosoncovt.com
Phone+1-800-689-7794
Emailsupport@bosoncovt.com
Phone+1-800-689-7794
Emailsupport@bosoncovt.com
Phone+1-800-689-7794
Emailsupport@bosoncovt.com
Phone+1-800-689-7794
Emailsupport@bosoncovt.com
Phone+1-800-689-7794
Emailsupport@bosoncovt.com
Phone+1-800-689-7794
Emailsupport@bosoncovt.com
Phone+1-800-689-7794
Emailsupport@bosoncovt.com
Phone+1-800-689-7794
Emailsupport@bosoncovt.com
Phone+1-800-689-7794
Emailsupport@bosoncovt.com
Phone+1-800-689-7794
Emailsupport@bosoncovt.com
Phone+1-800-689-7794
Emailsupport@bosoncovt.com
Phone+1-800-689-7794
Emailsupport@bosoncovt.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106921963712509 [Primary]
GS106921963715258 [Unit of Use]

FDA Product Code

QKPCoronavirus Antigen Detection Test System.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-03
Device Publish Date2022-09-24

Devices Manufactured by Xiamen Boson Biotech Co., Ltd.

06921963712493 - Boson - Rapid SARS-CoV-2 Antigen Test Card - 1 Tests/Kit2022-10-17 Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with sym
06921963712509 - Boson - Rapid SARS-CoV-2 Antigen Test Card - 2 Tests/Kit2022-10-03Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 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.
06921963712509 - Boson - Rapid SARS-CoV-2 Antigen Test Card - 2 Tests/Kit2022-10-03 Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with sym
06921963715258 - Boson - Rapid SARS-CoV-2 Antigen Test Card - 8 Tests/Kit2022-10-03 Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with sym
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