Identity
- Trade Name
- Hydrophilic Plus Slides FDA UDI
- Generic Name
- General specimen microscopy slide IVD, single-use FDA UDI
- Device Name
- The Hydrophilic Plus Microscope Slides are novel positively charged hydrophilic slides that prevent tissue detachment after thermal permeabilization and can be used to mount and process IHC, ICC, FISH and CISH samples including those to be subjected to Heat -Induced Epitope Retrieval (HIER) procedures. FDA UDI
- Model / Reference
- BSB 7028 FDA UDI
- Description
- The Hydrophilic Plus Microscope Slides are novel positively charged hydrophilic slides that prevent tissue detachment after thermal permeabilization and can be used to mount and process IHC, ICC, FISH and CISH samples including those to be subjected to Heat -Induced Epitope Retrieval (HIER) procedures. FDA UDI
Identifiers
- Catalog Number
- BSB 7028 FDA UDI
- Primary DI / UDI-DI
- B502BSB70280 FDA UDI
- FDA Product Code
- KEW FDA UDI
- GMDN Term
- General specimen microscopy slide IVD, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3010 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
Category: General specimen microscopy slide IVD, single-use
Hydrophilic Plus Slides 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 631b8417-f22b-4076-994c-92b8613b0260 36 fields · synced Jun 1, 2026