Eu Ivdr Eu Ivd Class A On The Market 🇩🇪 Germany

BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR

R-Biopharm AG · 🇩🇪 Germany
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
04049095200021
Basic UDI-DI Code
4049095TZ8805000065
Reference
TZ8805
Device Types
Single use Sterile
Regulation
Eu Ivdr
Classification
Eu Ivd Class A
Status
On The Market
Manufacturer
R-Biopharm AG

Additional Description

For in-vitro diagnostic use. The RIDA® TB Tubes are sterile blood collection tubes. They are intended for venous blood collection of human whole blood and subsequent Mycobacterium tuberculosis-specific induction of IP-10 in individuals with suspected M. tuberculosis infection (including disease). They are IVD specimen containers for the RIDASCREEN® TB (TC8806) or the RIDA®QUICK TB (TN8802). The RIDA® TB Tubes consist of a set of three blood collection tubes (negative control, positive control, test) per person to be tested. The product is intended for professional use

CND Nomenclature Codes

Code Description
W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR

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