Identity
- Trade Name
- HistoCore PELORIS FDA UDI
- Generic Name
- Tissue processor IVD, automated/semi-automated FDA UDI
- Device Name
- A barcode scanner, a built-in camera and an LCD screen t at displays the images captured by the camera. The scanner can be used for performing the same functions as a conventional barcode scanner and the built-in camera is used for capturing images of he baskets filled with cassettes. FDA UDI
- Model / Reference
- HistoCore I-Scan Kit FDA UDI
- Description
- A barcode scanner, a built-in camera and an LCD screen t at displays the images captured by the camera. The scanner can be used for performing the same functions as a conventional barcode scanner and the built-in camera is used for capturing images of he baskets filled with cassettes. FDA UDI
Identifiers
- Catalog Number
- S45.4507 FDA UDI
- Primary DI / UDI-DI
- 09349458005559 FDA UDI
- FDA Product Code
- IEO FDA UDI
- GMDN Term
- Tissue processor IVD, automated/semi-automated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3875 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
Yes
FDA UDI
Category: Tissue processor IVD, automated/semi-automated
HistoCore PELORIS by Leica Biosystems Melbourne Pty Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Thermo Fisher — SHANDON DIAGNOSTICS LIMITED · Class I
- Leica TP1020 (Single loading) without vacuum/ — Leica Biosystems Nussloch GmbH · Class I
- ASP6025 S 120V/50-60Hz — Leica Biosystems Nussloch GmbH · Class I
- Leica TP1020 (Double loading) Without vaccum/w — Leica Biosystems Nussloch GmbH · Class I
- Tissue-Tek Xpress® — Sakura Finetek USA, 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
- Leica Biosystems Melbourne Pty Ltd
Sources (1)
- FDA UDI 2c2d19fa-e5cf-4b2d-b641-1f231130c328 34 fields · synced May 30, 2026