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

Rotavirus and Adenovirus Combo Rapid Test

Devices (same UDI-DI)
3
Certificates
0
Countries
1
Notified Bodies
0

Basic Information

Primary DI
06936983104432
Basic UDI-DI Code
6970277510000DXH
Reference
IRAC-N625
Device Types
Single use
Regulation
Eu Ivdr
Classification
Eu Ivd Class B
Status
On The Market

Additional Description

"The Rotavirus and Adenovirus Combo Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of rotavirus and adenovirus in human feces specimens to aid in the diagnosis of rotavirus and/or adenovirus infection. The product is intended to be used by trained laboratory personnel. For laboratory use only. The test provides preliminary test results, negative results will not preclude Rotavirus/Adenovirus infection 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. "

CND Nomenclature Codes

Code Description
W0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER

Available In Countries

🇩🇪 Germany

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