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COVID-19 ANTIGEN Home Test

COVID-19 ANTIGEN Home Test
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COVID-19 ANTIGEN Home Test

Product catalog summary
Product Information
The Rapid SARS-CoV-2 Antigen Test Card by Xiamen Boson Biotech Co., Ltd. received Emergency Use Authorization (EUA) from the FDA on April 6, 2022. It is designed for home use to detect SARS-CoV-2 antigens in nasal swabs, providing results in 15 minutes. The test can detect multiple variants, including Delta and Omicron, with a production capacity of 10 million tests per day.

Test Procedures
The test involves a six-step process: setting up the buffer, swabbing both nostrils, placing the swab in the buffer tube, pinching the buffer tube, adding drops to the sample well, and reading the result after 15 minutes.

Packaging Specifications
The test kits are available in various sizes, ranging from 1 to 40 tests per kit, with corresponding box and carton dimensions and weights.

Authorizations and Certificates
The test is authorized under EUA for detecting SARS-CoV-2 proteins only. It is not FDA cleared or approved for other pathogens. The authorization is valid during the emergency declaration period.

Company Information
Xiamen Boson Biotech Co., Ltd., founded in 2001, specializes in in vitro diagnostic kits. The company operates under ISO 13485 and GMP guidelines, with products approved by China NMPA and CE certified. The company has exported over 700 million antigen tests globally.

Market Reach
Boson Biotech's products are exported to over 70 countries, including the UK, Germany, Italy, Brazil, and more.

Contact Information
For inquiries, contact [email protected], and for technical support, contact [email protected]. More information is available on their website: www.bosoncovt.com.
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Catalog excerpts

COVID-19 ANTIGEN Home Test-1

COVID-19 ANTIGEN Home Test EMERGENCY USE AUTHORIZATION XIAMEN BOSON BIOTECH CO., LTD.

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COVID-19 ANTIGEN Home Test-3

Rapid SARS-CoV-2 Antigen Test Card  FDA granted EUA for Rapid SARS-CoV-2 Antigen Test Card (Home Test) on April 6, 2022 A home test for rapid qualitative detection of SARS-CoV-2 virus antigen in anterior nasal swabs Daily production capacity of 10 million tests per day and still expanding Product Information  Sample type: nasal swab  Time to result: 15 min  Clinical study has met the requirements of FDA EUA  Multiple variants can be accurately detected, including Delta and Omicron

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COVID-19 ANTIGEN Home Test-4

Test Procedures Remove seal and place buffer in the tube holder Swab both nostrils Place swab in the buffer tube and wait for 1 min Add 3 drops into the sample well (S) Pinch the buffer tube

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COVID-19 ANTIGEN Home Test-6

Specifications Various packaging specifications available:  1 Test/Kit  2 Tests/Kit  4 Tests/Kit  5 Tests/Kit  8 Tests/Kit  10 Tests/Kit  20 Tests/Kit  40 Tests/Kit Components :  Test Card in sealed pouch  Pre-filled buffer  Sterilized swab  Tube holder (1&2 Tests/Kit on packaging)  Quick Reference Instructions Box/Carton Specifications 1 Test/Kit  Carton Size: Carton Size: Carton Size: Carton Size: Carton Size: Carton Size:

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COVID-19 ANTIGEN Home Test-7

Authorizations and Certificates FDA EUA Certificates • This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA; • This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and, • The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1),...

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COVID-19 ANTIGEN Home Test-8

Company Information Boson Introduction Xiamen Boson Biotech Co., Ltd., as a specialist of in vitro diagnostic kits field was founded in 2001, develops and manufactures high-quality point of care and other immunoassay test kits for the worldwide market. Our factory is operated strictly under ISO 13485 and GMP guidelines. Our product lines provide immunoassays in various formats to detect infectious diseases, cardiac markers, drugs of abuse, fertility hormones and tumor markers. Many of our products have been approved by the China NMPA and are CE certified. The Rapid SARS-CoV-2 Antigen Test Card...

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COVID-19 ANTIGEN Home Test-10

Medical Device Production License Issued by China Food and Drug Administration

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COVID-19 ANTIGEN Home Test-11

Our products have been exported to more than 70 countries, including: Britain, Germany, Italy, Brazil, Argentina, Australia, India, Malaysia, South Africa, etc.

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COVID-19 ANTIGEN Home Test-12

Contact Information Inquiry: [email protected] Technical Support: [email protected] Website: www.bosoncovt.com

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.