Genobio SARS-CoV-2 Neutralizing Antibody Rapid Test Colloidal Gold
19Pages

SARS-CoV-2 Neutralizing Antibody Rapid Test (Colloidal Gold) Summary Data

目录 (Contents) 1. 产品彩页（Product Brochure）…………………………………………………………..…………………1-4 2. 公司介绍（Company Profile）…………………………………………………………………………………5 3. 符合性声明（Declaration of Conformity）…………………………………………………………………6 4. CE 证书（CE Certificate）……………………………………………………………………...……………7-8 5. 说明书（Instruction for Use）…………………………………………………………..…………….……9-10 6. 包装信息（Packing Information）

Overview Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an enveloped non-segmented positive-sense RNA virus. It is the cause of coronavirus disease 2019 (COVID-19), which is easily transmitted person to person and person to objects. After emerging, patients infected by SARS-CoV-2 have been successively discovered all over the world in a short time, and is still spreading rapidly. Intended Use The product uses colloidal gold method for the in vitro qualitative detection of the COVID-19 neutralizing antibodies in human whole blood / serum / plasma / fingertip blood samples....

Operation Procedure 1. Sample Collection • Whole blood & Plasma & Serum: Collect according to the clinical collection guidelines for laboratory test specimens. It is recommended to test the specimen immediately after collection. Wipe to clean the puncture site on your finger with the alcohol pad. Use safty lancet and dropper tip to Test the specimen immedi- collect patient fingertip blood specimen ately after collection, according to the clinical collection guidelines for laboratory test specimens. Add a certain amount of specimen to the sample well (S) a. Fingertip blood & Whole blood: 20...

Innovation for Better Health ISO 'is©*' Tel: +86(22)60978609 ext. 8605/8606/8608/8609 Fax: +86(22)60978609-804 E-mail: marketing@era-bio.com / customer@era-bio.com Web: www.era-bio.com Add: 2-1,2,3-101, No.2 Zone, Binlv Industrial Park, Binhai Add: 1601, Building C2, TEDA MSD-C, No. 79, 1st Avenue, Tianjin Tourism Area, Binhai New Area, Tianjin 300480, P. R. China Economic-Technological Development Area, Tianjin 300457, Genobio is wholly-owned subsidiary of Era Biology Group -- Page 4 --

Company Profile Era Biology Group, started business operation in 1997, is one of the leaders and pioneers of invasive fungal disease diagnosis around the world. Now we have eight subsidaries: Beijing Gold Mountainriver Tech Development Co., Ltd., Genobio Pharmaceutical Co., Ltd., Era Biology (Shanghai) Co., Ltd., Era Biology (Guangzhou) Co., Ltd., Era Biology (Suzhou) Co., Ltd., Beihai Sinlon Biotech Co., Ltd., Era Biology Group, LLC., and Era Biology (Canada) Co., Ltd.. Era Biology has passed the authentications of CMD ISO 9001, ISO 13485, Korea GMP and North America MDSAP, and has most...

Whose Authorized Representative: Name: Lotus NL B.V. Address: Koningin Julianaplein 10,1 e Verd, 2595AA, The Hague, Netherlands. E-mail: peter@lotusnl.com Manufacturer: Name: Genobio Pharmaceutical Co., Ltd. Address: 2-1, 2, 3-101, No.2 Zone, Binlv Industrial Park, Binhai Tourism Area, Binhai New Area, Tianjin 300480, P. R. China Tel+86 (022) 60978665 Email: marketing@era-bio.com We, the manufacturer, here with declare that the product(s)

ICIBG Ministerie van Volksgezondheid, Welzijn en Sport > Retouradres Postbus 16114 2500 BC Den Haag Lotus NL B.V. T.a.v. de heer X. Wei Koningin Julianaplein 10 2595 AA 's-Gravenhage Farmatec Bezoekadres: Hoftoren Rijnstraat 50 2515 XP Den Haag T 070 340 6161 http://hulomiddelen.farmateo.nl Inlichtingen via: medlsche_hulpmiddelen@ minvws.nl Datum: 11 juni 2021 Betreft: aanmelding In-vitro diagnostica Geachte heer Wei, Op 1 juni 2021 ontving ik uw notificatie krachtens artikel 4, eerste lid van het Nederlandse Besluit in-vitro diagnostica (BIVD) om onderde bedrijfsnaam Genobio Pharmaceutical...

Notificatie van in-vitro diagnostische medische hulpmiddelen impliceert dat de fabrikant, Genobio Pharmaceutical Co., Ltd. de CE-conformiteitsmarkering heeft aangebracht op het desbetreffende product alvorens het in een EU-lidstaat in de handel te brengen. Zodoende garandeert Lotus NL B.V. dat het in-vitro diagnosticum voldoet aan de essentiele eisen zoals opgenomen in bijlage I bij Richtlijn 98/79/EG (en in het daarmee corresponderende onderdeel 1 bij het besluit) Volledigheidshalve wijzen wij u erop dat een in-vitro diagnosticum moet voldoen aan de eisen uit het BIVD. Het BIVD is...

Virusee® SARS-CoV-2 Neutralizing Antibody Rapid Test ( Colloidal Gold) Instruction for Use only for in vitro diagnostic and prqfessional use Please read thisIFU carefully before use! [Name] SARS-CoV-2 Neutralizing Antibody Rapid Test (Colloidal Gold) [Model Specification] VNAbLFA-01: 1 test kit VNAbLFA-20: 20 testskit [Intended use] The product is used for the in vitro qualitative detection of the COMD-19 neutralizing antibodies m human whole blood f serum / plasma / fingertip Wood samples The product is mainly used to monitor the infection rate of herd immunity and protective immunity, and...

Positive Two hues appear One colored line should be in the control region (Q, and another apparent colored line adjacent should be in the test line (T). Negative One colored line appears m the control region (Q. No line appears in the test lme (T). Invalid Control line fells to appear Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure Review the procedure and repeat the test using a new test cassette. If the problem persists, discontinue using the lot immediately and contact your local distnbutor. [Quality Control] A...