Identity
- Trade Name
- HistoCore PELORIS FDA UDI
- Generic Name
- Tissue processor IVD, automated/semi-automated FDA UDI
- Device Name
- The HistoCore PELORIS 3 dual retort rapid tissue processor automates preparation of tissue samples for sectioning. This is achieved by transforming fixed specimens into wax infiltrated specimens by exposing them to a sequence of reagents in the tissue processor. Tissue samples subsequently undergo interpretation by a qualified healthcare professional to aid diagnosis. FDA UDI
- Model / Reference
- HistoCore PELORIS 3 (100-120V) FDA UDI
- Description
- The HistoCore PELORIS 3 dual retort rapid tissue processor automates preparation of tissue samples for sectioning. This is achieved by transforming fixed specimens into wax infiltrated specimens by exposing them to a sequence of reagents in the tissue processor. Tissue samples subsequently undergo interpretation by a qualified healthcare professional to aid diagnosis. FDA UDI
Identifiers
- Catalog Number
- 49.0005 FDA UDI
- Primary DI / UDI-DI
- 09349458004811 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
No
FDA UDI
Serial Number
Yes
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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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 79aa1687-b357-4828-b74b-8775ea0e3bbf 34 fields · synced Jun 6, 2026