Eu Ivdr
Eu Ivd Class C
On The Market
🇨🇳 China
HE4 CLIA Microparticles
Devices (same UDI-DI)
2
Certificates
0
Countries
3
Notified Bodies
0
Basic Information
- Primary DI
- 06942359508995
- Basic UDI-DI Code
- 697015090000227HE
- Reference
- CMB1810
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class C
- Status
- On The Market
- Manufacturer
- Autobio Diagnostics Co., Ltd.
Additional Description
The HE4 CLIA Microparticles assay and AutoLumo HE4 Calibrators are used together based on a chemiluminescent microparticle immunoassay (CLIA Microparticles) for the quantitative determination of HE4 (human epididymal protein 4) in human serum. Clinical determination of HE4 is used as an aid in disease progression or treatment effectiveness, through the dynamic monitoring of patients with ovarian malignant tumors.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102030119 | HUMAN EPIDIDYMIS PROTEIN 4 |
Available In Countries
🇮🇹 Italy
🇷🇴 Romania
🇹🇷 Türkiye
Related Devices
The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).
CREATININE
Device
EU IVDR
·
Eu Ivd Class C
·Medicon Hellas SA·On the market·1 country
CREATININE
Device
EU IVDR
·
Eu Ivd Class C
·Medicon Hellas SA·On the market·1 country
MH Guide
Device
EU IVDR
·
Eu Ivd Class C
·Molecular Health GmbH·On the market·2 countries
CREATININE
Device
EU IVDR
·
Eu Ivd Class C
·Medicon Hellas SA·On the market·1 country
CREATININE
Device
EU IVDR
·
Eu Ivd Class C
·Medicon Hellas SA·On the market·1 country
CREATININE
Device
EU IVDR
·
Eu Ivd Class C
·Medicon Hellas SA·On the market·1 country