Prueba rápida COVID

IgG/IgM antibody test solution

The Food and Drug Administration

AGENCIA ESTATAL DE MEDICAMENTOS

Y TECNOLOGÍAS EN SALUD

www.insumosbolivia.com
Prueba rápida IgG/IgM insumos
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Prueba rápida individual IgG/IgM

con Agemed y certificaciones FDA y
CE.

Espécimen: Sangre/Plasma/Serum
Tiempo: 10 minutos
Sensibilidad: IgG 99% - IgM 98%
Especificidad: 100%
Contenido de la prueba insumos
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1 Buffer
1 Casette
1 Lanceta
1 Paño con alcohol
1 Gotero
1 Manual de uso
1 Caja (empaque)
Modo de uso insumos
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1. Desinfecte la punta del dedo con

el isopo de alcohol
2. Use la lanceta estéril para extraer
sangre de la punta del dedo
3. Recoja sangre con el gotero
4. Agregue una gota de sangre al
casette
5. Agregue lentamente
2 gotas de muestra
en el casette
6. Espere el
resultado10
minutos

10m
Tiempos de Prueba nula Prueba válida
detección Resultados
insumos
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Registro FDA insumos
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CERTIFICATE OF FDA REGISTRATION

Dear official Correspondent:
The document provides notification of the registration number
assigned to your establishment.

Establishment Name: Hangzhou Realy Tech Co.,Ltd.

4th Floor, #12 Building, Eastern Medicine

Address:
Town,Xiasha Economic & Technology
DevelopmentHangzhou Zhejiang,CN 310018
Email: info@realytech.com
Owner/Operator Number: 10062960
US Agent: MICHAEL O’NEILL
O’NEILL LLC
14 JOHN DAVENPORT DR
Suite 400
Rome , GA US 30165
Phone: 302 3736061 Ext
Email: Michael@Oneill.Us.Com

Listing Number Product Code Device Name Activities

REAGENT, CORONAVIRUS
Confidential QKO Manufacturer
SEROLOGICAL

Note:
General Manager
This file is not being issued by FDA.We,Hangzhou
Realy Tech Co.,Ltd.,as the manufacturer,produce it,
intended of facilitate client display & transmit information.
The following contents,FDA registered Facility information,
are excerpted from the database at www.fda.gov.
Registro FDA/EUA insumos
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Certificación CE insumos
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EC Declaration of Conformity
in accordance with Directive 98/79/EC

Manufacturer:

Name: HANGZHOU REALY TECH CO., LTD.

Address:4th Floor,#12 Building,Eastern Medicine Town,Xiasha
Economic&Technology Development,310018 Hangzhou,Zhejiang,P.R.China

Product/s Catalogue number

2019-nCOV IgG/IgM Rapid Test Device K460216D

Category: Other Devices (All devices except Annex II and self-testing devices)

Conformity assessment route: Annex III,except Point 6,of Directive

$SSOLFĮEOH6WĮQGĮUGV(1,62(1,62
EN ISO 14971:2012 ;EN ISO 13612:2002;EN ISO 17511:2003;
EN ISO 18113-1:2011;EN ISO 18113-2:2011,EN ISO 18113-3:2011;
EN ISO 23640:2015;EN 62366:2008.

We, the Manufacturer, herewith declare with sole responsibility that our product/s
mentioned above meet/s the provisions of the Directive 98/79/EC of the European
Parliament and of the Council on In-Vitro Diagnostic Medical Devices.

We hereby explicitly appoint Luxus Lebenswelt GmbH,located at Kochstr.1,47877,

Willich,Germany to act as our European Authorised Representative as defined in
the aforementioned Directive.

Hangzhou, February 16th 2020

(Place and date of issue) (Signature and position)

Signed for and on behalf of the manufacturer
Certificación ISO 1385 insumos
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Agemed/Registro Sanitario insumos
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Precio/Contacto insumos
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Precio por prueba: Bs. 120

Pedidos al por menor en:

www.insumosbolivia.com

Pedidos al por mayor

(arriba de 100 unidades)

76000076

78560778