Identity
- Trade Name
- ClaraBond™ Slide Coater Adhesive FDA UDI
- Generic Name
- Rotary microtome IVD FDA UDI
- Device Name
- Clarapath adhesive is intended to assist in the tissue transfer from the tape onto an unsoiled histology slide in SectionStar™ auto-sectioning machine. FDA UDI
- Model / Reference
- 900-00021 FDA UDI
- Description
- Clarapath adhesive is intended to assist in the tissue transfer from the tape onto an unsoiled histology slide in SectionStar™ auto-sectioning machine. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860012688920 FDA UDI
- FDA Product Code
- IDL FDA UDI
- GMDN Term
- Rotary microtome IVD 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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: Rotary microtome IVD
ClaraBond™ Slide Coater Adhesive by Clarapath, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rotary microtome IVD.
- Epredia — SHANDON DIAGNOSTICS LIMITED · Class I
- Accu-Cut® SRM™ 200 — Sakura Finetek USA, Inc · Class I
- Accu-Cut® SRM™ 300 LT — Sakura Finetek USA, Inc · Class I
- Accu-Cut® SRM™ 200 — Sakura Finetek USA, Inc · Class I
- Tissue-Tek AutoSection® — Sakura Finetek USA, Inc · Class I
- Accu-Cut® SRM™ 300 LT — Sakura Finetek USA, Inc · Class I
- Clarapath™ SectionStar™ — Clarapath, Inc. · Class I
- ClaraTape™ Transfer Tape — Clarapath, 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
- Clarapath, Inc.
Sources (1)
- FDA UDI 28f592f4-65fd-4971-973a-b0c4205168fc 33 fields · synced May 30, 2026