Identity
- Trade Name
- PAX-5 Control Slides FDA UDI
- Generic Name
- B-cell specific activator protein (BSAP) IVD, control FDA UDI
- Device Name
- PAX-5, Control Slides FDA UDI
- Model / Reference
- Control Slides, 5 FDA UDI
- Description
- PAX-5, Control Slides FDA UDI
Identifiers
- Catalog Number
- BSB 5867 FDA UDI
- Primary DI / UDI-DI
- B502BSB58670 FDA UDI
- FDA Product Code
- LJG FDA UDI
- GMDN Term
- B-cell specific activator protein (BSAP) 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: B-cell specific activator protein (BSAP) IVD, control
PAX-5 Control Slides by Bio Sb, 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
- Bio Sb, Inc.
Sources (1)
- FDA UDI ce4cf6bf-fb3b-4ab1-bd91-b56f98a261b2 34 fields · synced May 29, 2026