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Chromosome Analysis Suite Dx Software (ChAS Dx)
EUDAMEDFDA UDIClass C (EU MDR)
Ref 610525
Identity
- Trade Name
- Chromosome Analysis Suite Dx Software (ChAS Dx) EUDAMEDApplied Biosystems FDA UDI
- Generic Name
- Human genomic analysis interpretive software FDA UDI
- Device Name
- Chromosome Analysis Suite Dx Software (ChAS Dx), a part of CytoScan™ Dx Test EUDAMEDChromosome Analysis Suite Dx Software FDA UDI
- Model / Reference
- 610525 EUDAMED2.1 FDA UDI
- Description
- Chromosome Analysis Suite Dx Software FDA UDI
Identifiers
- Catalog Number
- 610525 FDA UDI
- Primary DI / UDI-DI
- 00856826006210 EUDAMEDFDA UDI
- Basic UDI-DI
- 0856826006610525FE EUDAMED
- FDA Product Code
- PFX FDA UDI
- EMDN Code
- W02079092 VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Human genomic analysis interpretive software FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5920 FDA UDI
- Special Device Type
- Software EUDAMED
- 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Chromosome Analysis Suite Dx Software (ChAS Dx) 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 | 0856826006610525FE | 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 a20cae97-3adb-4837-ae16-d53ee8888eea 61 fields · synced Jun 18, 2026
- FDA UDI f14f1174-952e-4d3e-a19e-eb64d9608727 34 fields · synced May 30, 2026