Identity
- Trade Name
- BOND FDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- The BOND System Control Kit provides the computer which contains the software (version 7.0) that controls the Processing Modules(s), as well as the Slide Labeler, Handheld barcode scanner, ethernet switch and power cable. FDA UDI
- Model / Reference
- BOND System Control Kit (version 7) FDA UDI
- Description
- The BOND System Control Kit provides the computer which contains the software (version 7.0) 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
- 49.0644 FDA UDI
- Primary DI / UDI-DI
- 09349458005504 FDA UDI
- FDA Product Code
- KPA FDA UDI
- GMDN Term
- Microscope slide stainer IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3800 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: Microscope slide stainer IVD
Bond 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 cd172ba2-d753-49fc-98bc-6d33eac5f6a3 34 fields · synced Jun 8, 2026