Identity
- Trade Name
- AGILITY EUDAMEDDYNEX Agility FDA UDI
- Generic Name
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
- Device Name
- AGILITY EUDAMEDAutomated ELISA Processing System with 12 Incubators FDA UDI
- Model / Reference
- 67000 EUDAMEDFDA UDIAGILITY EUDAMED
- Description
- Automated ELISA Processing System with 12 Incubators FDA UDI
Identifiers
- Catalog Number
- 67000 FDA UDI
- Primary DI / UDI-DI
- 05060456180058 EUDAMEDFDA UDI
- Basic UDI-DI
- 506045618AGILITYBB 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
Yes
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Multiple clinical chemistry analyser IVD, laboratory
DYNEX Agility 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
IVDR
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 c2b5c387-a724-4cd2-aeaa-83146695c9e8 36 fields · synced Aug 1, 2026
- EUDAMED 596d307a-f0fa-422e-9a7e-c40a85c3084b 61 fields · synced Aug 1, 2026