Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
Devices (same UDI-DI)
1
Certificates
0
Countries
13
Notified Bodies
0
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Basic Information
- Primary DI
- 06941571818301
- Basic UDI-DI Code
- B-06941571818301
- Reference
- R183-116
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Additional Description
Human Fatty Acid Binding Protein (h-FABP) is a sensitive biomarker for myocardial necrosis. H-FABP can be used to confirm or exclude a diagnosis of acute myocardial infarction (AMI) and for monitoring of a recurrent infarction. The h-FABP Test is a rapid assay test. The analytical sensitivity of the test is 8 ng/ml. This test is intended for professional use as an aid in detecting acute myocardial infarction.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160705 | HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC |
Available In Countries
🇨🇿 Czechia
🇩🇪 Germany
🇬🇷 Greece
🇪🇸 Spain
🇫🇮 Finland
🇫🇷 France
🇮🇸 Iceland
🇮🇹 Italy
🇱🇹 Lithuania
🇱🇻 Latvia
🇳🇱 Netherlands
🇵🇱 Poland
🇷🇴 Romania
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