Identity
- Trade Name
- Cytokeratin 20 control slides FDA UDI
- Generic Name
- Cytokeratin IVD, control FDA UDI
- Device Name
- Cytokeratin 20 Control FDA UDI
- Model / Reference
- Control Slides, 5 FDA UDI
- Description
- Cytokeratin 20 Control FDA UDI
Identifiers
- Catalog Number
- BSB 5392 FDA UDI
- Primary DI / UDI-DI
- B502BSB53920 FDA UDI
- FDA Product Code
- LJG FDA UDI
- GMDN Term
- Cytokeratin IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2660 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Cytokeratin IVD, control
A comprehensive medical device directory listing for the Cytokeratin 20 Control Slides, including its features, regulatory compliance, and FAQs.
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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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bio Sb, Inc.
Sources (1)
- FDA UDI 596998db-847a-4ad6-b432-1d127ed7d172 34 fields · synced Jun 20, 2026