Identity
- Trade Name
- Dako FDA UDI
- Generic Name
- Multiple CD cell marker IVD, antibody FDA UDI
- Device Name
- DuoFLEX Cocktail Anti-CD3 Anti-CD20cy Ready-to-Use (Link) FDA UDI
- Model / Reference
- IC002 FDA UDI
- Description
- DuoFLEX Cocktail Anti-CD3 Anti-CD20cy Ready-to-Use (Link) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700571105597 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Multiple CD cell marker IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Commercial Distribution
- 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
Dimensions & Sizes
- Size
- Total Volume — 6 Milliliter FDA UDI
Category: Multiple CD cell marker IVD, antibody
Dako by Agilent Technologies Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 1db6c510-e80b-4f6d-98be-0567fe1de4de 36 fields · synced May 30, 2026