FDA UDI
In Commercial Distribution
🇺🇸 United States
BOND
DI: 09349458004859
·
Model: BOND Controller (6.0/W10 loT)
·
LEICA BIOSYSTEMS MELBOURNE PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BOND
- Primary DI
- 09349458004859
- Version / Model
- BOND Controller (6.0/W10 loT)
- Catalog Number
- S21.4621
- Company Name
- LEICA BIOSYSTEMS MELBOURNE PTY LTD
- Labeler DUNS
- 753184944
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-18
- Public Version
- 1
- Public Version Date
- 2022-07-26
- Public Version Status
- New
- Public Device Record Key
- f0465639-2da5-4917-868a-0c1bb52fe257
Device Description
The BOND Controller provides the computer that contains the software (version 6.0/W10 IoT) that controls the processing Module(s).
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KPA | Slide Stainer, Automated | Pathology | 864.3800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15599 | Microscope slide stainer IVD | An automated mains electricity (AC-powered) laboratory instrument intended to be used to stain blood, tissue and/or other clinical specimens fixed to microscope examination slides, using one or more biological or cytochemical staining solutions in preparation for subsequent microscopic analysis. The device operates with minimal technician involvement and complete automation of all procedural steps. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09349458004859 | GS1 |