Eu Ivdd Eu Ivd General No Longer On The Market 🇪🇬 Egypt

NS BIOTEC Chemistry Analyzer

NS BIOTEC · 🇪🇬 Egypt
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
D-ChemistryAnalyzerHC
Basic UDI-DI Code
B-ChemistryAnalyzerHC
Reference
SCA 1000/1200
Device Types
None provided
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
No Longer On The Market
Manufacturer
NS BIOTEC

Additional Description

(Multiple clinical chemistry analyser IVD, laboratory, semi-automated) An electrically-powered laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents, using one or multiple technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

CND Nomenclature Codes

Code Description
W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)

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