Eu Ivdr
Eu Ivd Class A
On The Market
🇨🇳 China
Coagulation Analyzer
Devices (same UDI-DI)
1
Certificates
0
Countries
1
Notified Bodies
0
Basic Information
- Primary DI
- 06975838800587
- Basic UDI-DI Code
- 697583880MC100MB
- Reference
- HE10004
- Device Types
-
Single use
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- Zhejiang Pushkang Biotechnology Co., Ltd.
Additional Description
The MC100 coagulation analyzer adopts the coagulation method for clinical determination of prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB) indicators; adopts immunoturbidimetric method for clinical determination Determine D-Dimer (D-Dimer) index. This instrument is suitable for laboratories with professional testing capabilities in medical institutions, such as central laboratories, outpatient and emergency laboratories, clinical departments, physical examination centers. For in vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201040102 | BLOOD GAS ANALYSERS - WITH ADDITIONAL PARAMETERS (pH, pO2, pCO2, Hct + metabolites + electrolytes, CO-oximeter parameters and coagulation parameters) |
Available In Countries
🇳🇱 Netherlands
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