DEVICE: BioPlex 2200 (00847865002264)

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Device Identifier (DI) Information
BioPlex 2200
SW4_V2
In Commercial Distribution
6652470C
BIO-RAD LABORATORIES, INC.
00847865002264
GS1

1
884513334 *Terms of Use
MMRV IgG Assay Protocol File CD, SW4_v2
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
No
No
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
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
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
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FDA Product Code

[?]
Product Code Product Code Name
LFY ENZYME LINKED IMMUNOABSORBENT ASSAY, VARICELLA-ZOSTER
OPL Multiplex immunoassay for measles virus, mumps virus, rubella and varicella zoster virus
LJB Enzyme linked immunoabsorbent assay, rubeola IgG
LJY ENZYME LINKED IMMUNOABSORBENT ASSAY, MUMPS VIRUS
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 1 Each
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Device Record Status
545c840e-15e6-434e-85fe-78939bc45878
March 29, 2018
2
September 12, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)224-6723
TechSupport.USSD@bio-rad.com
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