Eu Ivdr Eu Ivd Class B On The Market 🇨🇳 China

FOB Rapid Test

Devices (same UDI-DI)
9
Certificates
0
Countries
1
Notified Bodies
0

Basic Information

Primary DI
06936983104418
Basic UDI-DI Code
6970277510000BXD
Reference
TFO-N602
Device Types
Single use
Regulation
Eu Ivdr
Classification
Eu Ivd Class B
Status
On The Market

Additional Description

"The FOB Rapid Test is a lateral flow rapid chromatographic immunoassay for the qualitative detection of Human Occult Blood in feces. The FOB Rapid Test is intended to be used by trained laboratory personnel. For laboratory use only. The test provides preliminary test results and they can't be used as the sole basis for treatment or other management decision. Not for Self-testing use. Not for near-patient use. Not for detection of colorectal tumor and other gastrointestinal tumors. "

CND Nomenclature Codes

Code Description
W0101060301 GUAIAC-BASED FECAL FAECAL OCCULT BLOOD (CC)

Available In Countries

🇩🇪 Germany

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The Basic UDI-DI associated with this device has 9 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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