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
- 00816870024448
- Basic UDI-DI Code
- 081687002IN006-3UR
- Reference
- IN006-3
- 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 G3 (ChemWell 5101) is designed for use in processing general chemistry, enzyme-linked immunosorbent assays (“ELISA” or “EIA”) and chemiluminescense immunoassay (“CLIA” or “CIA”) 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) |
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