Identity
- Trade Name
- DS2 Automated ELISA System with Barcode scanner EUDAMEDDYNEX DS2 FDA UDI
- Generic Name
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
- Device Name
- DS2 Automated ELISA System EUDAMEDDS2 Automated ELISA Processing System, with Barcode Scanner FDA UDI
- Model / Reference
- 62010 EUDAMEDFDA UDIDS2 EUDAMED
- Description
- DS2 Automated ELISA Processing System, with Barcode Scanner FDA UDI
Identifiers
- Catalog Number
- 62010 FDA UDI
- Primary DI / UDI-DI
- 05060456180003 EUDAMEDFDA UDI
- Basic UDI-DI
- 506045618DS2DE EUDAMED
- FDA Product Code
- LXG FDA UDIJJQ FDA UDIJQW FDA UDI
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED
- GMDN Term
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 FDA UDI862.2300 FDA UDI862.2750 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple clinical chemistry analyser IVD, laboratory
Dynex Ds2 by Dynex Technologies, Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Multiple clinical chemistry analyser IVD, laboratory.
- ZELLECHEM-PRO — STERILE SAFEQUIP & CHEMICALS LLP · Class I
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class I
- ABX PENTRA 400 ISE — Horiba Abx · Class I
- IDS-iSYS Cuvettes — IMMUNODIAGNOSTIC SYSTEMS FRANCE · Class I
- Alinity — Abbott Laboratories, Inc. · Class I
- Alinity — Abbott Laboratories, Inc. · Class I
- ABS800 Chemistry Analyzer — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- ABX PENTRA 400 ISE — Horiba Abx · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dynex Technologies, Inc.
Sources (2)
- FDA UDI b86f63d1-a4cb-495d-bcfd-3c785dbaa244 36 fields · synced Jul 23, 2026
- EUDAMED 030105eb-142b-4d0a-b5ce-f604e7e375fb 61 fields · synced Jul 23, 2026