Identity
- Trade Name
- BOND System Control Kit (6.0/W10 loT) EUDAMEDBOND FDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- BOND Processing Module EUDAMEDThe BOND System Control Kit provides the computer which contains the software (version 6.0/W10 IoT) that controls the Processing Modules(s), as well as the Slide Labeler, Handheld barcode scanner, ethernet switch and power cable. FDA UDI
- Model / Reference
- 21.2793 EUDAMEDBOND System Control Kit (6.0/W10 loT) FDA UDI
- Description
- The BOND System Control Kit provides the computer which contains the software (version 6.0/W10 IoT) that controls the Processing Modules(s), as well as the Slide Labeler, Handheld barcode scanner, ethernet switch and power cable. FDA UDI
Identifiers
- Catalog Number
- 21.2793 FDA UDI
- Primary DI / UDI-DI
- 09349458005450 EUDAMEDFDA UDI
- Basic UDI-DI
- 9349458001D9 EUDAMED
- FDA Product Code
- KPA FDA UDI
- EMDN Code
- W0202059002 AUTOMATED SLIDE STAINERS EUDAMED
- GMDN Term
- Microscope slide stainer IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
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: Microscope slide stainer IVD
Bond by Leica Biosystems Melbourne Pty Ltd — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| 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 (2)
- FDA UDI ffa9a16e-023d-4ebb-9f07-6747612ec347 34 fields · synced Jul 10, 2026
- EUDAMED 7d40a95f-bf72-49f9-baea-b4a8c841530a 61 fields · synced Jul 10, 2026