Identity
- Trade Name
- CEACAM7 Control Slides FDA UDI
- Generic Name
- Carcinoembryonic antigen (CEA) IVD, control FDA UDI
- Device Name
- CEACAM7 Control Slides FDA UDI
- Model / Reference
- BSB-9249-CS FDA UDI
- Description
- CEACAM7 Control Slides FDA UDI
Identifiers
- Catalog Number
- BSB-9249-CS FDA UDI
- Primary DI / UDI-DI
- B502BSB9249CS0 FDA UDI
- FDA Product Code
- LJG FDA UDI
- GMDN Term
- Carcinoembryonic antigen (CEA) 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Carcinoembryonic antigen (CEA) IVD, control
CEACAM7 Control Slides by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carcinoembryonic antigen (CEA) IVD, control.
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- Alinity — Abbott Ireland Diagnostics · Class II
- CEA Control Slides — BIO SB, INC. · Class I
- CEA Control Slides — BIO SB, INC. · Class I
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 9e364241-4aa3-4866-9089-7dc7498dd1dc 36 fields · synced May 30, 2026