Eu Ivdr
Eu Ivd Class A
On The Market
🇺🇸 United States
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 00816870020075
- Basic UDI-DI Code
- 081687002IN006ZU
- Reference
- IN006
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- Monobind Inc.
Additional Description
For In-Vitro Diagnostic Use. AutoPlex G1 (ChemWell 2980) is designed for use in processing general chemistry and enzyme-linked immunosorbent assays (“ELISA” or “EIA”), including clinical diagnostic assays, requiring multi-step washing, rinsing, and soaking. This general purpose instrument is intended to be used by laboratory professionals who are capable of selecting the appropriate features and options for each specific clinical application.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201020101 | AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) |
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