Identity
- Trade Name
- GCDC Dx Installer v1.0 EUDAMEDApplied Biosystems FDA UDI
- Generic Name
- Microarray analyser IVD FDA UDI
- Device Name
- GeneChip™ System 3000Dx v.2 Instrument System EUDAMEDGeneChip™ Data Collection Dx FDA UDI
- Model / Reference
- 611403 (00-0334) EUDAMED1.0 FDA UDI
- Description
- GeneChip™ Data Collection Dx FDA UDI
Identifiers
- Catalog Number
- 611403 FDA UDI
- Primary DI / UDI-DI
- 00856826006203 EUDAMEDFDA UDI
- Basic UDI-DI
- 0856826006000334CC EUDAMED
- FDA Product Code
- NSU FDA UDI
- EMDN Code
- W02050201 MICRO-ARRAY ANALYSERS EUDAMED
- GMDN Term
- Microarray analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.2570 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
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
GCDC Dx Installer v1.0 by Affymetrix, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0856826006000334CC | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Affymetrix, Inc.
- EUDAMED SRN
- US-MF-000028847
- Authorised Representative
- Life Technologies Europe B.V. NL-AR-000021890
Sources (2)
- EUDAMED 4579fc28-47bb-43a1-8d3c-33e7fdb33174 61 fields · synced Jul 9, 2026
- FDA UDI ceb71892-a900-4711-a617-67cf7bb192b5 34 fields · synced May 24, 2026