Identity
- Trade Name
- SureFISH ALK 3' BA 300kb P5GR FDA UDI
- Generic Name
- Nucleic acid hybridization detection IVD, reagent FDA UDI
- Device Name
- SureFISH ALK 3' BA 300kb P5GR FDA UDI
- Model / Reference
- G110908G FDA UDI
- Description
- SureFISH ALK 3' BA 300kb P5GR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700574022792 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 ALK 3' BA 300kb P5GR 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 8baf8a02-01b9-4f46-ac4d-7d23a7b3eaae 37 fields · synced Jun 8, 2026