
Catalog excerpts

COVID-19 ANTIGEN Home Test EMERGENCY USE AUTHORIZATION XIAMEN BOSON BIOTECH CO., LTD.
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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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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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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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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. §...
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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...
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Medical Device Production License Issued by China Food and Drug Administration
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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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Contact Information Inquiry: info@bosoncovt.com Technical Support: support@bosoncovt.com Website: www.bosoncovt.com
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