Eu Ivdr
Eu Ivd Class A
On The Market
🇩🇰 Denmark
LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 05744003280117
- Basic UDI-DI Code
- 574400328REAGK8U
- Reference
- RLA700
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- RefLab Aps
Additional Description
Intended purpose The device is a consumable, which is used for performing the basophil histamine release assay (BHRA). The RLA700 reagent kit consists of reagents for the test completion of the BHRA methods that involves fluorometric detection of histamine. For in vitro diagnostic use. Intended user Reagent kit is for professional (health care) use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201020285 | LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class A) and regulation (EU IVDR).
Automatic Tissue Processor
Device
EU IVDR
·
Eu Ivd Class A
·Dakewe (Shenzhen) Medical Equipment Co., Ltd.·On the market·32 countries
CELL COUNTING INSTRUMENTS - OTHER
Device
EU IVDR
·
Eu Ivd Class A
·Zhuji Zhiwei Information and Technology Ltd.·On the market
Magnetic Immunoassay System
Device
EU IVDR
·
Eu Ivd Class A
·Shenzhen BOSH Diagnostics, Ltd.·On the market
ReaScan+
Device
EU IVDR
·
Eu Ivd Class A
·Reagena Oy·On the market·32 countries
Labtub
Device
EU IVDR
·
Eu Ivd Class A
·Lingen Precision Medical Products (Shanghai) Co., Ltd.·On the market
Labtub
Device
EU IVDR
·
Eu Ivd Class A
·Lingen Precision Medical Products (Shanghai) Co., Ltd.·On the market