COVID-19 ANTIGEN Home Test
EMERGENCY USE AUTHORIZATION
XIAMEN BOSON BIOTECH CO., LTD.
Rapid SARS-CoV-2 Antigen Test Card 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 being expanded
Product Information Performance Characteristics Sample type: nasal swab Time to result: 15-20 min Clinical study finished by Tricore Reference Laboratories and has met the requirement of FDA EUA Multiple variants can be accurately detected, including Delta and Omicron
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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 contained: 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
2 Tests/Kit
4 Tests/Kit
5 Tests/Kit
Box Size:
Box Size:
Box Size:
Box Size:
155*60*15mm
155*60*17mm
155*60*32mm
155*60*37mm
Carton Size:
Carton Size:
Carton Size:
Carton Size:
335*420*350mm
335*470*350mm
335*335*350mm
335*410*350mm
Gross Weigh: 7.8kg 250 tests (250 boxes)/carton
8 Tests/Kit Box Size:
Gross Weigh: 10.0kg 500 tests (250 boxes)/carton
10 Tests/Kit Box Size:
Gross Weigh: 6.9kg
Gross Weigh: 8.3kg
400 tests (100 boxes)/carton
500 tests (100 boxes)/carton
20 Tests/Kit
40 Tests/Kit
Box Size:
Box Size:
155*60*50mm
155*60*60mm
155*120*60mm
205*145*65mm
Carton Size:
Carton Size:
Carton Size:
Carton Size:
335*550*350mm
335*650*350mm
335*640*350mm
435*615*375mm
Gross Weigh: 12.6kg 800 tests (100 boxes)/carton
Gross Weigh: 14.5kg 1000 tests (100 boxes)/carton
Gross Weigh: 14.5kg 1000 tests (50 boxes)/carton
Gross Weigh: 19.6kg 1600 tests (40 boxes)/carton
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Test Procedures When you are ready to perform the test, remove the seal from the buffer tube and place the tube in the tube holder.
Peel open the swab packaging and gently take out the swab. Holding the stick end of the swab, gently insert the entire absorbent tip of the swab into the nostril no more than ½ to ¾ inch. There is no need to go deeper. Slowly rotate the swab in a circular motion 5 times by firmly pressing against the inside walls of the nostril for a total of 15 seconds. Do not just spin the swab. Gently remove the swab and repeat in the other nostril using the same swab.
Place swab into buffer tube. Rotate swab 5 times. Set a timer and leave swab in buffer tube for 1 minute.
Pinch buffer tube with fingers and remove the solution from swab as much as possible. Press the cap onto the buffer tube until it is secure.
Open the pouch and remove the test cassette. Place the cassette on a flat and level surface. Invert the buffer tube and add 3 drops of test sample into the sample well (S) by gently squeezing the extraction tube. Do not add test sample to the rectangular results window. Set a timer and read the results at 15 minutes.
Interpretation of Results
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Authorizations and Certificates CE Certificate by Notified Body
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China Export White List from CCCMHPIE
Source: http://www.cccmhpie.org.cn/Pub/6325/179329.shtml Name List of Medical Devices and Supplies Companies with Certification/Authorization from other Countries Status of No.
Company
Uniform Social Credit Code
Certification / Authorization
Province
Product Model
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Xiamen 60
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Quantitative Test 91350200705468594R
CE
FuJian
SARS-CoV-2 Neutralizing Antibody Test Card SARS-CoV-2 Neutralizing Antibody Quantitative Test SARS-CoV-2 Antigen Saliva Test Card Anti-SARS-CoV-2 S Protein Antibody Test Card
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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, we develop and manufacture high-quality point of care and other immunoassay test kits for wouldwide market. Our factory is operated strictly under ISO 13485 and GMP guidelines. Our product lines provide the 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 China NMPA and CE. Rapid SARS-CoV-2 Antigen Test Card for self-testing manufactured by Xiamen Boson Biotech obtained the world’s first CE certificate issued by a notified body on 1st April of 2021. Up to 2021, BOSON exported more than 700 million tests of antigen test products to the EU and other countries, helping many countries to prevent and control the spread of the epidemic. Xiamen Boson Biotech’s mission is to provide the affordable high-quality products to help fight diseases.
Automated Production Lines
Manual Production Lines
Warehouse
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ISO 13485 Certificate
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Medical Device Production License
February 11, 2022
Prepared by China Food and Drug Administration
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Our Market
Our products have been exported to more than 70 countries: 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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