Identity
- Trade Name
- GenetiSure Dx Labeling 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 Labeling Kit FDA UDI
- Model / Reference
- K1201-64105 EUDAMEDFDA UDI
- Description
- GenetiSure Dx Labeling Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700571112601 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
Yes
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 Labeling 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 486153e5-9ffe-4599-9a8b-78229981aea7 61 fields · synced Jul 9, 2026
- FDA UDI a1478ae1-f5ee-496d-a5f2-cbc3bd796757 36 fields · synced May 30, 2026