Identity
- Trade Name
- SureFISH 16q22.1 CBFB DF 498kb P20 GR FDA UDI
- Generic Name
- Nucleic acid hybridization detection IVD, reagent FDA UDI
- Device Name
- SureFISH 16q22.1 CBFB DF 498kb P20 GR FDA UDI
- Model / Reference
- G110422G FDA UDI
- Description
- SureFISH 16q22.1 CBFB DF 498kb P20 GR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700574033330 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Nucleic acid hybridization detection IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
SureFISH 16q22.1 CBFB DF 498kb P20 GR by Agilent Technologies Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Agilent Technologies Inc.
Sources (1)
- FDA UDI 3b09292e-114f-49bf-9a7a-e7c2b4d0be83 37 fields · synced May 30, 2026