Identity
- Trade Name
- HER-3/c-erbB-3 control slides FDA UDI
- Generic Name
- Her3 protein IVD, control FDA UDI
- Device Name
- HER-3/c-erbB-3 Control FDA UDI
- Model / Reference
- Control Slides, 5 FDA UDI
- Description
- HER-3/c-erbB-3 Control FDA UDI
Identifiers
- Catalog Number
- BSB 2635 FDA UDI
- Primary DI / UDI-DI
- B502BSB26350 FDA UDI
- FDA Product Code
- LJG FDA UDI
- GMDN Term
- Her3 protein 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: Her3 protein IVD, control
HER-3/c-erbB-3 control slides by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Her3 protein IVD, control.
- HER-3/c-erbB-3 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 9e3a85b2-9022-4ac7-90c7-14edd20985dc 34 fields · synced May 31, 2026