FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BioPlex 2200
DI: 00847865001175
·
Model: 6653850
·
BIO-RAD LABORATORIES, INC.
Product Codes
3
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BioPlex 2200
- Primary DI
- 00847865001175
- Version / Model
- 6653850
- Catalog Number
- 6653850
- Company Name
- BIO-RAD LABORATORIES, INC.
- Labeler DUNS
- 884513334
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 6
- Public Version Date
- 2021-07-29
- Public Version Status
- Update
- Public Device Record Key
- fd8a645f-4993-42e9-8be3-7b9e99fe0990
- Distribution End Date
- 2021-07-06
Device Description
Rubella & CMV IgM 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 |
|---|---|---|---|---|
| LFX | ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA | Microbiology | 866.3510 | 2 |
| LFZ | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | Microbiology | 866.3175 | 2 |
| LKQ | ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS | Microbiology | 866.3175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50269 | Rubella virus 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 Rubella virus in a clinical specimen, using a fluorescent immunoassay method. | No | Active |
| 49725 | Cytomegalovirus (CMV) 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 cytomegalovirus (CMV) in a clinical specimen, using a fluorescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00847865001175 | 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