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Documents for Clongene COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P) 1

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Page 1: DocumentsforClongeneCOVID-19IgG/IgMRapidTestCassette(WB… · (WB/S/P)-lCOV4212 Other according to aticle 9 of directive 98/79/EC meets the provisions of the directive 98/79/EC and

Documents for Clongene COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)

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Page 2: DocumentsforClongeneCOVID-19IgG/IgMRapidTestCassette(WB… · (WB/S/P)-lCOV4212 Other according to aticle 9 of directive 98/79/EC meets the provisions of the directive 98/79/EC and

Documents for Clongene COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)

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BUSINESS LICENSE-ENGLISH VERSION

Page 3: DocumentsforClongeneCOVID-19IgG/IgMRapidTestCassette(WB… · (WB/S/P)-lCOV4212 Other according to aticle 9 of directive 98/79/EC meets the provisions of the directive 98/79/EC and

Documents for Clongene COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)

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MEDICAL DEVICE PRODUCTION LICENSE

Page 4: DocumentsforClongeneCOVID-19IgG/IgMRapidTestCassette(WB… · (WB/S/P)-lCOV4212 Other according to aticle 9 of directive 98/79/EC meets the provisions of the directive 98/79/EC and

Documents for Clongene COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)

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CERTIFICATE-ISO13485:2016

Page 5: DocumentsforClongeneCOVID-19IgG/IgMRapidTestCassette(WB… · (WB/S/P)-lCOV4212 Other according to aticle 9 of directive 98/79/EC meets the provisions of the directive 98/79/EC and

Documents for Clongene COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)

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EC Declaration of Conformity

Page 6: DocumentsforClongeneCOVID-19IgG/IgMRapidTestCassette(WB… · (WB/S/P)-lCOV4212 Other according to aticle 9 of directive 98/79/EC meets the provisions of the directive 98/79/EC and

Documents for Clongene COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)

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Australia TGA

Page 7: DocumentsforClongeneCOVID-19IgG/IgMRapidTestCassette(WB… · (WB/S/P)-lCOV4212 Other according to aticle 9 of directive 98/79/EC meets the provisions of the directive 98/79/EC and

Documents for Clongene COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)

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US FDA

Page 8: DocumentsforClongeneCOVID-19IgG/IgMRapidTestCassette(WB… · (WB/S/P)-lCOV4212 Other according to aticle 9 of directive 98/79/EC meets the provisions of the directive 98/79/EC and

Documents for Clongene COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)

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BRAZIL ANVISA

Page 9: DocumentsforClongeneCOVID-19IgG/IgMRapidTestCassette(WB… · (WB/S/P)-lCOV4212 Other according to aticle 9 of directive 98/79/EC meets the provisions of the directive 98/79/EC and

Documents for Clongene COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)

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CERTIFICATES-ISO9001:2015

Page 10: DocumentsforClongeneCOVID-19IgG/IgMRapidTestCassette(WB… · (WB/S/P)-lCOV4212 Other according to aticle 9 of directive 98/79/EC meets the provisions of the directive 98/79/EC and

Documents for Clongene COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)

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CERTIFICATES-ISO45001:2018

Page 11: DocumentsforClongeneCOVID-19IgG/IgMRapidTestCassette(WB… · (WB/S/P)-lCOV4212 Other according to aticle 9 of directive 98/79/EC meets the provisions of the directive 98/79/EC and

Documents for Clongene COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)

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CERTIFICATES-ISO14001:2015

Page 12: DocumentsforClongeneCOVID-19IgG/IgMRapidTestCassette(WB… · (WB/S/P)-lCOV4212 Other according to aticle 9 of directive 98/79/EC meets the provisions of the directive 98/79/EC and

Documents for Clongene COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)

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Certificate of Analyses

Page 13: DocumentsforClongeneCOVID-19IgG/IgMRapidTestCassette(WB… · (WB/S/P)-lCOV4212 Other according to aticle 9 of directive 98/79/EC meets the provisions of the directive 98/79/EC and

Documents for Clongene COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)

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Instruction for Use

Page 14: DocumentsforClongeneCOVID-19IgG/IgMRapidTestCassette(WB… · (WB/S/P)-lCOV4212 Other according to aticle 9 of directive 98/79/EC meets the provisions of the directive 98/79/EC and

Documents for Clongene COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)

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Instruction for Use

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Documents for Clongene COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)

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Packing Details:

ICOV4212-100496:25Tests+25Droppers+25safety lancets+25alcohol pads+25individualbuffer+1Package insert/box,1250pcs/CTN; Carton size:64*34*55cm,G.W.:16.8kgs