15’ · 2020. 9. 7. · covid-19 igg/igm rapid test cassette 15’ componenti del test kit type of...

COVID-19 IgG/IgM Rapid Test Cassette 15’ Componenti del Test Kit Type of Technology: Chromatographic Lateral Flow Immunoassay Antibody Type: IgM/IgG Sample Type: Whole Blood/Serum/Plasma Time to Result: 10-20 minutes. Do not read after 20 minutes. Shelf Life of Test Kit: 12 Months. Test Kit Components: IFU, 1 Foil Pouch (containing Test Cassette), 1 lancet, 1 pipette, 1 buffer solution vial. • Provides fast results in under 15 minutes. • Easy to interpret results with 5 conclusions: Negative, IgG & IgM Positive, IgM Only Positive, IgG Only Positive, Invalid. • Detects both IgM and IgG Antibodies. • As simple as a glucose test. • No advanced training required. • Each kit contains everything required to administer test. • Made in EU and CE Certified IVD Negative IgG and IgM Positive IgG Only Positive Invalid Test Invalid Test Invalid Test Invalid Test IgM Only Positive 1 4 2 5 6 3 SARS-CoV-2 IgM/IgG antibody test kit is intended for the in vitro qualitative detection of SARS-CoV-2 IgM and IgG antibodies from human serum, plasma and whole blood samples. The SARS-CoV-2 IgM/IgG rapid test is based on the immunochromatographic method. The SARS- CoV-2 specific IgM/IgG antibodies are detected by SARS-CoV-2 recombinant antigen and mouse anti human IgM/IgG antibodies. PRODUCT CERTIFIED “CE IVD” – REGISTRATION NUM. 1977342 AXELMED S.R.L. Via della Liberazione, 58 / IT 20098 S. Giuliano Milanese (MI) / Italy Tel: +39 02 9828 2694 / Fax: +39 02 9828 5327 / [email protected] C.F. e P.IVA (VAT#): IT 09541170966 / R.E.A. MI 2097286 / ISO 13485:2016 Certified Company www.myaxelmed.com / Axelmed ® and Paradigma ® are trade marks PRODUZIONE DISPOSITIVI MEDICI MEDICAL DEVICES MANUFACTURING Complete SET to carry out 25 tests independently or with unskilled personnel: • 25 Test Cassettes • 25 blood pipettes • 25 finger lancers • 1 lancer penjet • 1 battle of Diluent for 25 tests

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COVID-19 IgG/IgMRapid Test Cassette

15’Componenti del Test Kit Type of Technology: Chromatographic Lateral Flow Immunoassay Antibody Type: IgM/IgG Sample Type: Whole Blood/Serum/PlasmaTime to Result: 10-20 minutes. Do not read after 20 minutes.

Shelf Life of Test Kit: 12 Months. Test Kit Components: IFU, 1 Foil Pouch (containing Test Cassette), 1 lancet, 1 pipette, 1 buffer solution vial.

• Provides fast results in under 15 minutes.• Easy to interpret results with 5 conclusions: Negative, IgG & IgM Positive, IgM Only Positive, IgG Only Positive, Invalid.• Detects both IgM and IgG Antibodies.• As simple as a glucose test.• No advanced training required.• Each kit contains everything required to administer test.• Made in EU and CE Certified IVD

Negative IgG and IgMPositive

IgG Only Positive

InvalidTest

InvalidTest

InvalidTest

InvalidTest

IgM OnlyPositive

1

4

2

5 6

3

SARS-CoV-2 IgM/IgG antibody test kit is intended for the in vitro qualitative detection of SARS-CoV-2 IgM and IgG antibodies from human serum, plasma and whole blood samples. The SARS-CoV-2 IgM/IgG rapid test is based on the immunochromatographic method. The SARS-CoV-2 specific IgM/IgG antibodies are detected by SARS-CoV-2 recombinant antigen and mouse anti human IgM/IgG antibodies.PRODUCT CERTIFIED “CE IVD” – REGISTRATION NUM. 1977342

AXELMED S.R.L.Via della Liberazione, 58 / IT 20098 S. Giuliano Milanese (MI) / ItalyTel: +39 02 9828 2694 / Fax: +39 02 9828 5327 / [email protected]. e P.IVA (VAT#): IT 09541170966 / R.E.A. MI 2097286 / ISO 13485:2016 Certified Companywww.myaxelmed.com / Axelmed® and Paradigma® are trade marks

PRODUZIONE DISPOSITIVI MEDICIMEDICAL DEVICES MANUFACTURING

Complete SET to carry out 25 tests independently or with unskilled personnel:

• 25 Test Cassettes

• 25 blood pipettes

• 25 finger lancers

• 1 lancer penjet

• 1 battle of Diluent for 25 tests