BioPlex 2200
- Primary DI
- 00847865000291
- Brand
- BioPlex 2200
- Company
- BIO-RAD LABORATORIES, INC.
- Model
- 6651350
- Catalog number
- 6651350
- Device description
- EBV IgG Reagent Pack
- Published
- 2016-09-12
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| KTN | SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KTN | System, Test, Infectious Mononucleosis | Immunology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00847865000291 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00847865000291 | 00847865000291 | 847865000291 | 0847865000291 |
GMDN Terms
| Term | Definition |
|---|
| Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Epstein-Barr virus (EBV) in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 884513334
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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