Identity
- Trade Name
- GenetiSure Dx Hybridization Kit EUDAMEDFDA UDI
- Generic Name
- Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- GenetiSure Dx Universal aCGH Reagents EUDAMEDGenetiSure Dx Hybridization Kit FDA UDI
- Model / Reference
- K1201-64200 EUDAMEDFDA UDI
- Description
- GenetiSure Dx Hybridization Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700571112625 EUDAMEDFDA UDI
- Basic UDI-DI
- 570057R0801P3011A040100QM EUDAMED
- FDA Product Code
- PFX FDA UDI
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED
- GMDN Term
- Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5920 FDA UDI
- Market of Registration
- Denmark 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
Yes
EUDAMED
Animal Tissues
Yes
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
No
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
GenetiSure Dx Hybridization Kit by Agilent Technologies 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 | 570057R0801P3011A040100QM | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Agilent Technologies, Inc.
- EUDAMED SRN
- US-MF-000009385
- Authorised Representative
- Agilent Technologies Denmark ApS DK-AR-000001443
Sources (2)
- EUDAMED 48dd4f17-1915-4ff1-99cb-eb4534c1b599 61 fields · synced Aug 2, 2026
- FDA UDI d76b7cb6-5508-4246-86e4-d14b1c481094 36 fields · synced May 30, 2026