FDA UDI
In Commercial Distribution
🇺🇸 United States
TintoAutomation Probe Cleaner Kit
DI: B502BSB74630
·
Model: BSB-7463
·
BIO SB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TintoAutomation Probe Cleaner Kit
- Primary DI
- B502BSB74630
- Version / Model
- BSB-7463
- Catalog Number
- BSB-7463
- Company Name
- BIO SB, INC.
- Labeler DUNS
- 102855447
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-18
- Public Version
- 1
- Public Version Date
- 2025-03-26
- Public Version Status
- New
- Public Device Record Key
- d3124c22-ebfb-4918-a395-e85a87300b88
Device Description
The TintoAutomation Cleaner is a 3-component cleaning solution for removal of DAB chromogen stains and precipitates from the TintoStainer Plus automated platform, glassware, labware, or other surfaces that come in contact with DAB.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33543 | Microscope slide tray | A device designed to safely store and organize stained microscope slides for their protection and presentation. This device is available as flat tray made of plastic materials in which the slides are placed flat into recesses. It will typically be made of white material to provide a background that facilitates slide viewing. This device will typically be placed in a microscope slide storage cabinet. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B502BSB74630 | HIBCC |
Customer Contacts
- Phone
- +1(800)561-1145
- [email protected]