Identity
- Trade Name
- Kappa / FITC control slides FDA UDI
- Generic Name
- Kappa/lambda light chain immunoglobulin IVD, control FDA UDI
- Device Name
- Kappa / FITC control FDA UDI
- Model / Reference
- control slides, 5 FDA UDI
- Description
- Kappa / FITC control FDA UDI
Identifiers
- Catalog Number
- BSB 3009-CS FDA UDI
- Primary DI / UDI-DI
- B502BSB3009CS0 FDA UDI
- FDA Product Code
- LJG FDA UDI
- GMDN Term
- Kappa/lambda light chain immunoglobulin 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: Kappa/lambda light chain immunoglobulin IVD, control
Kappa / FITC control slides by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- N FLC CONTROL SL2 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
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 387538c7-7730-48fe-80bd-898c3b876350 34 fields · synced May 30, 2026