Eu Ivdd Eu Ivd General No Longer On The Market 🇫🇮 Finland

Amplidiag Easy Process Control I 

Mobidiag Ltd. · 🇫🇮 Finland
Devices (same UDI-DI)
1
Certificates
0
Countries
4
Notified Bodies
0

Basic Information

Primary DI
06430041761143
Basic UDI-DI Code
B-06430041761143
Reference
AE-RC802x8
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
No Longer On The Market
Manufacturer
Mobidiag Ltd.

Additional Description

Amplidiag Easy Process Control I is designed for controlling the extraction process when running stool samples using Amplidiag workflow. Amplidiag Easy Process Control I is added to each extraction reaction together with sample and extraction reagents before extraction with Amplidiag Easy instrument. Amplidiag Easy Process Control I is then amplified using selected Amplidiag assay kits and analyzed using Amplidiag Analyzer where pre-determined acceptance criteria determines if process control is accepted or failed. Amplidiag Easy Process Control I contains synthetic dsDNA fragment and ssRNA fragment with yeast tRNA as carrier.

CND Nomenclature Codes

Code Description
W01040699 CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER

Available In Countries

🇫🇮 Finland 🇫🇷 France 🇳🇴 Norway 🇸🇪 Sweden

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