Eu Ivdr
Eu Ivd Class B
On The Market
🇺🇸 United States
α-AMYLASE
Devices (same UDI-DI)
1
Certificates
0
Countries
32
Notified Bodies
0
Basic Information
- Primary DI
- 15099590000035
- Basic UDI-DI Code
- 150995901OSR6006LS
- Reference
- OSR6006
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Beckman Coulter Inc.
Additional Description
Alpha(α)-Amylase reagent is an in vitro diagnostic medical device intended to be used by healthcare professionals for the quantitative kinetic colour measurement of α-amylase in human serum, plasma and urine using the automated Beckman Coulter AU/DxC AU analyzers. Measurement of α-amylase is intended to be used as an aid in the diagnosis of pancreatic disorders.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01010199 | ENZYMES - OTHER |
Available In Countries
🇦🇹 Austria
🇧🇪 Belgium
🇧🇬 Bulgaria
🇨🇾 Cyprus
🇨🇿 Czechia
🇩🇪 Germany
🇩🇰 Denmark
🇪🇪 Estonia
🇬🇷 Greece
🇪🇸 Spain
🇫🇮 Finland
🇫🇷 France
🇭🇷 Croatia
🇭🇺 Hungary
🇮🇪 Ireland
🇮🇸 Iceland
🇮🇹 Italy
🇱🇮 Liechtenstein
🇱🇹 Lithuania
🇱🇺 Luxembourg
🇱🇻 Latvia
🇲🇹 Malta
🇳🇱 Netherlands
🇳🇴 Norway
🇵🇱 Poland
🇵🇹 Portugal
🇷🇴 Romania
🇸🇪 Sweden
🇸🇮 Slovenia
🇸🇰 Slovakia
🇹🇷 Türkiye
🇬🇧 United Kingdom
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