Identity
- Trade Name
- CytoLayer Slide treatment Solution FDA UDI
- Generic Name
- Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry FDA UDI
- Device Name
- The CytoLayer Slide Treatment Solution is intended to be used to treat the Hydrophylic Plus Slides prior to sedimentation of liquid cytology samples. This treatment significantly improves adherence of cells to the slide surface and is critical for reliable processing of liquid cytology samples. FDA UDI
- Model / Reference
- 500 ml FDA UDI
- Description
- The CytoLayer Slide Treatment Solution is intended to be used to treat the Hydrophylic Plus Slides prior to sedimentation of liquid cytology samples. This treatment significantly improves adherence of cells to the slide surface and is critical for reliable processing of liquid cytology samples. FDA UDI
Identifiers
- Catalog Number
- BSB 4027 FDA UDI
- Primary DI / UDI-DI
- B502BSB40270 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 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: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
CytoLayer Slide treatment Solution 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 0a78ff18-a638-4480-ad3d-1bc05f9c7989 34 fields · synced Jun 8, 2026