Identity
- Trade Name
- CytoScan Dx Array, 6 pk EUDAMEDAffymetrix FDA UDI
- Generic Name
- Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- CytoScan Dx Assay, a part of CytoScan™ Dx Test EUDAMEDCytoScan™ Dx Array, 6 pk FDA UDI
- Model / Reference
- 902150 (902420) EUDAMED902150 FDA UDI
- Description
- CytoScan™ Dx Array, 6 pk FDA UDI
Identifiers
- Catalog Number
- 902150 FDA UDI
- Primary DI / UDI-DI
- 00856826006098 EUDAMEDFDA UDI
- Basic UDI-DI
- 0856826006902420G9 EUDAMED
- FDA Product Code
- PFX FDA UDI
- EMDN Code
- W0106010399 CHROMOSOMAL DISORDERS TESTS - OTHER EUDAMED
- GMDN Term
- Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5920 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
Yes
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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
CytoScan Dx Array, 6 pk by Affymetrix, Inc. — Class C — 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 | 0856826006902420G9 | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | 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 b2dcea0a-15e2-4f83-a849-5963357dd7dd 61 fields · synced Jul 13, 2026
- FDA UDI b41c92f5-9f1a-4d73-ab15-7709b03310d2 34 fields · synced May 30, 2026