Identity
- Trade Name
- ClearLLab FDA UDI
- Generic Name
- Multiple CD cell marker IVD, antibody FDA UDI
- Device Name
- ClearLLab M FDA UDI
- Model / Reference
- M FDA UDI
- Description
- ClearLLab M FDA UDI
Identifiers
- Catalog Number
- B66812 FDA UDI
- Primary DI / UDI-DI
- 15099590671013 FDA UDI
- FDA Product Code
- PWD FDA UDI
- GMDN Term
- Multiple CD cell marker IVD, antibody FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Multiple CD cell marker IVD, antibody
ClearLLab by Beckman Coulter Ireland Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter Ireland Inc.
Sources (1)
- FDA UDI 81ea9a34-8f29-4b6f-a445-8b7f9e19ead1 35 fields · synced Jun 6, 2026