FDA UDI
In Commercial Distribution
🇺🇸 United States
TintoStainer 36 Slide (110V) with Report Printer + UPS
DI: B502BSB70290
·
Model: TintoStainer 36 (110V)
·
BIO SB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TintoStainer 36 Slide (110V) with Report Printer + UPS
- Primary DI
- B502BSB70290
- Version / Model
- TintoStainer 36 (110V)
- Catalog Number
- BSB 7029
- Company Name
- BIO SB, INC.
- Labeler DUNS
- 102855447
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-30
- Public Version
- 1
- Public Version Date
- 2020-10-08
- Public Version Status
- New
- Public Device Record Key
- 23ee9000-7993-4e73-a8e6-cefb6d7e0db3
Device Description
The Bio SB Automated TintoStainer is an automated 36, 48, or 72 slide system for use in Immunohistochemistry (IHC) and Immunocytochemistry (ICC). The TintoStainer is perfect for laboratories that have a need increase work-flow efficiency through automation, yet want to maintain low operating costs. The TintoStainer is a rapid, flexible, open and affordable solution which allows for fast implementation of laboratory protocols while keeping a compact footprint.
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 | B502BSB70290 | HIBCC |