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TintoStainer Plus Automated System LX
FDA UDIClass I (US FDA UDI)
by Bio Sb, Inc.
Identity
- Trade Name
- TintoStainer Plus Automated System LX FDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- Fully automated immunohistochemical system. Completes the whole process from deparaffinization through counterstain, impproving work efficiency in the laboratory. 60 Slides. FDA UDI
- Model / Reference
- BSB-7400-60 FDA UDI
- Description
- Fully automated immunohistochemical system. Completes the whole process from deparaffinization through counterstain, impproving work efficiency in the laboratory. 60 Slides. FDA UDI
Identifiers
- Catalog Number
- BSB-7400-60 FDA UDI
- Primary DI / UDI-DI
- B502BSB7400600 FDA UDI
- FDA Product Code
- KPA FDA UDI
- GMDN Term
- Microscope slide stainer IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3800 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Microscope slide stainer IVD
TintoStainer Plus Automated System LX by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Bio Sb, Inc.
Sources (1)
- FDA UDI 377a40a1-c8b8-4736-bce5-93278b89b859 36 fields · synced May 30, 2026