Tinto Detector Complete System
- Primary DI
- B502BSB70000
- Brand
- Tinto Detector Complete System
- Company
- BIO SB, INC.
- Model
- BSB 7000
- Catalog number
- BSB 7000
- Device description
- Accessory of the Tinto Stainer Plus Automated System
- Published
- 2025-03-18
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B502BSB70000 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Regulatory Flags
- DUNS number
- 102855447
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| B502BSB52580 | CD45RA (4KB5) MMab | Concentrate, 1 ml | BSB 5258 | 2020-03-16 |
| B502BSB74000 | TintoStainer Plus Automated System | BSB-7400 | BSB-7400 | 2025-03-28 |
| B502BSB7400100 | TintoStainer Plus Automated System Mini | BSB-7400-10 | BSB-7400-10 | 2025-03-28 |
| B502BSB7400600 | TintoStainer Plus Automated System LX | BSB-7400-60 | BSB-7400-60 | 2025-03-28 |
| B502BSB9420CS0 | Tryptase Control Slides | BSB-9420-CS | BSB-9420-CS | 2025-03-28 |
| B502BSB02010 | Mouse/Rabbit PolyDetector DAB HRP Brown | BSB 0201 | BSB 0201 | 2025-03-18 |
| B502BSB0307CS0 | 5-Core Multi-Infectious Disease Cell Line Microarray Control Slides | BSB-0307-CS | BSB-0307-CS | 2025-03-18 |
| B502BSB0307S0 | Mohs Mouse/Rabbit PolyDetector DAB HRP Brown | BSB 0307S | BSB 0307S | 2025-03-18 |
| B502BSB0308CS0 | 2-Core SV-40 Cell Line Microarray Control Slides | BSB-0308-CS | BSB-0308-CS | 2025-03-18 |
| B502BSB0309CS0 | 2-Core HHV-8 Cell Line Microarray Control Slides | BSB-0309-CS | BSB-0309-CS | 2025-03-18 |
| B502BSB0310CS0 | 2-Core Adenovirus Cell Line Microarray Control Slides | BSB-0310-CS | BSB-0310-CS | 2025-03-18 |
| B502BSB0333CS0 | 2-core Human PIN TMA Control Slides | BSB-0333-CS | BSB-0333-CS | 2025-03-18 |
| B502BSB0352150 | PIN MultiDetector (CK 34BE12, p63 & AMACR) | BSB-0352-15 | BSB-0352-15 | 2025-03-18 |
| B502BSB0352500 | PIN MultiDetector (CK 34BE12, p63 & AMACR) | BSB-0352-50 | BSB-0352-50 | 2025-03-18 |
| B502BSB0353500 | PNI Carcinoma MultiDetector (CK 5 & 6 Cocktail & NGFR) | BSB-0353-50 | BSB-0353-50 | 2025-03-18 |
| B502BSB03551000 | Mohs Mouse/Rabbit PolyDetector Plus DAB HRP Brown | BSB-0355-100 | BSB-0355-100 | 2025-03-18 |
| B502BSB0355150 | Mohs Mouse/Rabbit PolyDetector Plus DAB HRP Brown | BSB-0355-15 | BSB-0355-15 | 2025-03-18 |
| B502BSB035550 | Mohs Mouse/Rabbit PolyDetector Plus DAB HRP Brown | BSB-0355-5 | BSB-0355-5 | 2025-03-18 |
| B502BSB0355500 | Mohs Mouse/Rabbit PolyDetector Plus DAB HRP Brown | BSB-0355-50 | BSB-0355-50 | 2025-03-18 |
| B502BSB03561000 | Mohs Mouse/Rabbit PolyDetector Plus HRP Green | BSB-0356-100 | BSB-0356-100 | 2025-03-18 |
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