FDA UDI
In Commercial Distribution
🇺🇸 United States
BioPlex 2200
DI: 00847865000291
·
Model: 6651350
·
BIO-RAD LABORATORIES, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BioPlex 2200
- Primary DI
- 00847865000291
- Version / Model
- 6651350
- Catalog Number
- 6651350
- Company Name
- BIO-RAD LABORATORIES, INC.
- Labeler DUNS
- 884513334
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 7
- Public Version Date
- 2021-07-29
- Public Version Status
- Update
- Public Device Record Key
- 21f1ae64-f639-4e6c-8796-449b966ba406
Device Description
EBV IgG Reagent Pack
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KTN | SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS | Immunology | 866.5640 | 2 |
| LJN | ANTIBODY IGM, IF, EPSTEIN-BARR VIRUS | Microbiology | 866.3235 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49663 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00847865000291 | GS1 |
Customer Contacts
- Phone
- +1(800)224-6723
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 100 Tests |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius