Eu Ivdr
Eu Ivd Class C
On The Market
🇨🇳 China
AutoLumo PCT Calibrators
Devices (same UDI-DI)
2
Certificates
0
Countries
3
Notified Bodies
0
Basic Information
- Primary DI
- 06975577177513
- Basic UDI-DI Code
- 697015090000043H2
- Reference
- CA100601
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class C
- Status
- On The Market
- Manufacturer
- Autobio Diagnostics Co., Ltd.
Additional Description
The PCT CLIA Microparticles assay and AutoLumo PCT Calibrators are used together based on the fully automated chemiluminescent microparticle immunoassay (CLIA Microparticles) system for the quantitative determination of PCT (Procalcitonin) in human serum and plasma (heparin, EDTA). PCT is used as an aid in 1) the early detection and dynamic monitoring of clinically relevant bacterial infections; 2) prognosis of sepsis.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102152204 | CARDIAC MARKER STANDARDS AND CALIBRATORS |
Available In Countries
🇮🇹 Italy
🇷🇴 Romania
🇹🇷 Türkiye
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