Eu Ivdr Eu Ivd Class A Not Intended For Eu Market 🇩🇪 Germany

AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)

R-Biopharm AG · 🇩🇪 Germany
Devices (same UDI-DI)
2
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
04049095260278
Basic UDI-DI Code
4049095ZG3101CNS0ZE
Reference
ZG3101CNS
Device Types
None provided
Regulation
Eu Ivdr
Classification
Eu Ivd Class A
Status
Not Intended For Eu Market
Manufacturer
R-Biopharm AG

Additional Description

For in-vitro diagnostic use. The RIDA qLine® SysToBlot is a combination of the RIDA qLine® autoBlot and RIDA qLine® Soft. The RIDA qLine® autoBlot is a fully automated analyzer for the processing of line blots. The product adopts immunoblotting method and must be used in combination with compatible reagents to detect specific antibodies in human serum or plasma samples. The RIDA qLine®Soft software is to be used for the automatic evaluation of scanned or photographed color intensities of a biochemical reaction in comparison to the background of the membrane. The product is intended for professional use.

CND Nomenclature Codes

Code Description
W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)

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