Identity
- Trade Name
- DSX Automated ELISA System - Ambient EUDAMEDDYNEX DSX FDA UDI
- Generic Name
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
- Device Name
- DSX Automated ELISA System EUDAMEDAutomated ELISA Processing System with 0 Incubators FDA UDI
- Model / Reference
- 65100 EUDAMEDFDA UDIDSX EUDAMED
- Description
- Automated ELISA Processing System with 0 Incubators FDA UDI
Identifiers
- Catalog Number
- 65100 FDA UDI
- Primary DI / UDI-DI
- 05060456180287 EUDAMEDFDA UDI
- Basic UDI-DI
- 506045618DSXFQ 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
- Spain 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
Yes
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 Dsx by Dynex Technologies, Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Dynex Technologies, Inc.
Sources (2)
- FDA UDI 5df93263-0575-479a-97bf-0f3c6170d1d3 36 fields · synced Jul 18, 2026
- EUDAMED 42c8de21-6f10-4ed2-8e02-9403f48b3f2a 61 fields · synced Jul 18, 2026