DEVICE: BioPlex 2200 (00847865000765)
Device Identifier (DI) Information
BioPlex 2200
6652450
In Commercial Distribution
6652450
BIO-RAD LABORATORIES, INC.
6652450
In Commercial Distribution
6652450
BIO-RAD LABORATORIES, INC.
MMRV IgG Reagent Pack
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| Yes | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 49291 | Measles virus immunoglobulin G (IgG) 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 G (IgG) antibodies to Measles virus in a clinical specimen, using a fluorescent immunoassay method.
|
Active | false |
| 49623 | Varicella-zoster virus (VZV) immunoglobulin G (IgG) 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 G (IgG) antibodies to varicella-zoster virus (VZV) in a clinical specimen, using a fluorescent immunoassay method.
|
Active | false |
| 49333 | Mumps virus immunoglobulin G (IgG) 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 G (IgG) antibodies to Mumps virus in a clinical specimen, using a fluorescent immunoassay method.
|
Active | false |
| 50266 | Rubella virus immunoglobulin G (IgG) 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 G (IgG) antibodies to Rubella virus in a clinical specimen, using a fluorescent immunoassay method.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| LFY | ENZYME LINKED IMMUNOABSORBENT ASSAY, VARICELLA-ZOSTER |
| LJY | ENZYME LINKED IMMUNOABSORBENT ASSAY, MUMPS VIRUS |
| OPL | Multiplex immunoassay for measles virus, mumps virus, rubella and varicella zoster virus |
| LJB | Enzyme linked immunoabsorbent assay, rubeola IgG |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: 100 Tests |
Device Record Status
61f80232-3f93-426a-b36f-404a5ba5c8ec
July 29, 2021
6
September 12, 2016
July 29, 2021
6
September 12, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)224-6723
TechSupport.USSD@bio-rad.com
TechSupport.USSD@bio-rad.com