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.

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

• Primary Device ID: 06921963712509
• NIH Device Record Key: 70a2e92f-71b1-498c-a4e8-6cc9c80ec6e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Boson - Rapid SARS-CoV-2 Antigen Test Card - 2 Tests/Kit
• Version Model Number: 1N40C5-2-US
• Company DUNS: 527409818
• Company Name: Xiamen Boson Biotech Co., Ltd.
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Customer Support Contacts

• Phone: +1-800-689-7794
• Email: support@bosoncovt.com
• Phone: +1-800-689-7794
• Email: support@bosoncovt.com
• Phone: +1-800-689-7794
• Email: support@bosoncovt.com
• Phone: +1-800-689-7794
• Email: support@bosoncovt.com
• Phone: +1-800-689-7794
• Email: support@bosoncovt.com
• Phone: +1-800-689-7794
• Email: support@bosoncovt.com
• Phone: +1-800-689-7794
• Email: support@bosoncovt.com
• Phone: +1-800-689-7794
• Email: support@bosoncovt.com
• Phone: +1-800-689-7794
• Email: support@bosoncovt.com
• Phone: +1-800-689-7794
• Email: support@bosoncovt.com
• Phone: +1-800-689-7794
• Email: support@bosoncovt.com
• Phone: +1-800-689-7794
• Email: support@bosoncovt.com
• Phone: +1-800-689-7794
• Email: support@bosoncovt.com
• Phone: +1-800-689-7794
• Email: support@bosoncovt.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06921963712509 [Primary]
GS1	06921963715258 [Unit of Use]

FDA Product Code

• QKP: Coronavirus Antigen Detection Test System.

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-03
• Device Publish Date: 2022-09-24

Devices Manufactured by Xiamen Boson Biotech Co., Ltd.

• 06921963712493 - Boson - Rapid SARS-CoV-2 Antigen Test Card - 1 Tests/Kit: 2022-10-17 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/Kit: 2022-10-03Non-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/Kit: 2022-10-03 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/Kit: 2022-10-03 Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with sym