Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

PGB One Step Pregabalin Test (Urine)

Sejoy Biomedical Co., Ltd. · 🇨🇳 China
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
06939663977814
Basic UDI-DI Code
B-06939663977814
Reference
Strip,Cassette,Panel,Cup
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market

Additional Description

The PGB One Step Pregabalin Test (Urine) detects Pregabalin through visual interpretation of color development on the strip. Drug conjugates are immobilized on the test region of the membrane. During testing, the specimen reacts with antibodies conjugated to colored particles and precoated on the sample pad. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there are insufficient drug molecules in the specimen, the antibody-colored particle conjugate will bind to the drug conjugates, forming a colored band at the test region of the membrane.

CND Nomenclature Codes

Code Description
W0102160599 DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER

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