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Sign in to claim this brandLEICA BIOSYSTEMS MELBOURNE PTY LTD
US
Last updated May 27, 2026
What LEICA BIOSYSTEMS MELBOURNE PTY LTD makes
The company produces automated and semi-automated tissue processors for in vitro diagnostic (IVD) use, designed to prepare tissue samples for histological analysis. It also manufactures microscope slide stainers and hybridization/denaturation incubators for IVD applications, including devices like the HistoCore PELORIS and ThermoBrite Elite Instrument. These products are used in pathology labs to streamline tissue processing and staining workflows.
The portfolio consists of Class I medical devices, which are generally considered low-risk and subject to minimal regulatory oversight. These devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance tracking in the United States. The company operates under the regulatory framework of the US market.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Leica Biosystems Melbourne Pty Ltd manufacture?
Leica Biosystems Melbourne Pty Ltd specializes in in vitro diagnostic (IVD) devices primarily used in pathology labs. Their portfolio includes automated and semi-automated tissue processors, which prepare tissue samples for histological analysis, as well as microscope slide stainers and hybridization/denaturation incubators. These devices are designed to automate and streamline workflows for preparing slides and processing tissues, such as the HistoCore PELORIS and ThermoBrite Elite Instrument.
Where is Leica Biosystems Melbourne Pty Ltd based, and which regulatory markets do their devices serve?
Leica Biosystems Melbourne Pty Ltd is based in the United States. Their devices are listed in the FDA’s Unique Device Identifier (UDI) database, indicating compliance with US regulatory requirements. The company’s products are intended for use in the US market under the applicable regulatory framework for Class I medical devices.
How are the devices manufactured by Leica Biosystems Melbourne Pty Ltd classified under regulatory standards?
The devices produced by Leica Biosystems Melbourne Pty Ltd fall under Class I medical device classification. Class I devices are generally considered low-risk and typically require minimal regulatory oversight, as they pose the least risk to patient safety. This classification aligns with their use in automated tissue processing and slide preparation workflows.
Which regulatory registries or databases list the devices made by Leica Biosystems Melbourne Pty Ltd?
The devices manufactured by Leica Biosystems Melbourne Pty Ltd are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for medical devices in the United States, helping to maintain transparency and accountability in the supply chain.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 753184944
Catalogue (32)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HistoCore PELORIS | HistoCore PELORIS 3 Barcode Scanner Kit | FDA UDI | Class I | Active |
| Bond | Zebra ZD421 Label Printer Spare | FDA UDI | Class I | Active |
| Bond | BOND System Control Kit (6.0/W10 loT) | EUDAMEDFDA UDI | Class I | Active |
| Bond | BOND Slide Labels and Printing Ribbon | FDA UDI | Class I | Active |
| Bond | BOND Universal Covertiles – 100 Pack | FDA UDI | Class I | Active |
| ThermoBrite Elite Instrument | 3800-007000-001 | FDA UDI | Class I | Active |
| Bond | Printer Ribbon & Labels for Cognitive Cxi (6 Pack) | FDA UDI | Class I | Active |
| Bond | BOND-ADVANCE Controller (7.0) | FDA UDI | Class I | Active |
| Bond | BOND-ADVANCE Terminal (6.0/W10 loT) | FDA UDI | Class I | Active |
| HistoCore PELORIS | HistoCore PELORIS 3 Win10 Upgrade Kit | FDA UDI | Class I | Active |
| HistoCore PELORIS | HistoCore I-Scan Kit | FDA UDI | Class I | Active |
| HistoCore PELORIS | Basket Spaced | FDA UDI | Class I | Active |
| Bond | BOND Cognitive Slide Labeller | FDA UDI | Class I | Active |
| Bond | BOND-ADVANCE Controller (6.0) | FDA UDI | Class I | Active |
| Bond | BOND-ADVANCE Terminal (7.0) | FDA UDI | Class I | Active |
| Bond | Printer Ribbon & Labels for Cognitive Cxi (6 Pack) | FDA UDI | Class I | Active |
| Bond | BOND Printer Ribbon & Labels Cxi (6 Pack) | FDA UDI | Class I | Active |
| Bond-Prime | BOND-PRIME ARC REFRESH KIT | FDA UDI | Class I | Active |
| HistoCore PELORIS | HistoCore PELORIS 3 (100-120V) | FDA UDI | Class I | Active |
| HistoCore PELORIS | HistoCore PELORIS 3 Win10/I-Scan Upgrade Kit | FDA UDI | Class I | Active |
| Bond | BOND Controller (7.0) | FDA UDI | Class I | Active |
| Bond | BOND Mixing Stations (5 pack) | FDA UDI | Class I | Active |
| Bond | BOND Controller (6.0/W10 loT) | EUDAMEDFDA UDI | Class I | Active |
| Bond | BOND Printer Ribbon & Labels Cxi (1 Pack) | FDA UDI | Class I | Active |
| Bond | BOND Handheld Barcode Scanner | FDA UDI | Class I | Active |
| Bond | Zebra GX430t Label Printer Spare | FDA UDI | Class I | Active |
| HistoCore PELORIS | High Capacity Basket (with dividers) | FDA UDI | Class I | Active |
| Bond | BOND System Control Kit (version 7) | FDA UDI | Class I | Active |
| Bond | BOND Universal Covertiles (pack of 160) | FDA UDI | Class I | Active |
| Bond | Cognitive Labeller | FDA UDI | Class I | Active |
| HistoCore PELORIS | Spaced Basket Kit | FDA UDI | Class I | Active |
| HistoCore PELORIS | High Capacity Basket Kit | FDA UDI | Class I | Active |
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