Biotestcell® 3
- Primary DI
- 07611969952687
- Brand
- Biotestcell® 3
- Company
- Bio-Rad Medical Diagnostics GmbH
- Model
- 816085100
- Catalog number
- 816085100
- Device description
- Reagent Red Blood Cells; 3.0 - 3.4%; for use in detection of unexpected antibodies with TANGO instruments and by tube test; 3x10ml
- Published
- 2015-07-23
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 07611969952687 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 07611969952687 | 07611969952687 | 7611969952687 |
GMDN Terms
| Term | Definition |
|---|
| Antibody screening reagent red blood cell IVD, kit, agglutination | A collection of two or three specifically characterized reagent red blood cells that are supplied together as a set and intended to be used when screening a clinical specimen to detect antibodies to red blood cell antigens, using an agglutination method. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 312576506
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- true
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company