DEVICE: BioPlex 2200 (00847865011075)

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Device Record History
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Device Identifier (DI) Information
BioPlex 2200
SW4.1_1
In Commercial Distribution
6651665E
BIO-RAD LABORATORIES, INC.
00847865011075
GS1

1
884513334 *Terms of Use
U.S. IFU, Manual & CDs, ToRC IgG IFU, SW4.1_v1
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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?
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
52437 Toxoplasma gondii 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 the parasitic protozoan Toxoplasma gondii in a clinical specimen, using a fluorescent immunoassay method.
Active false
49714 Cytomegalovirus (CMV) 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 cytomegalovirus (CMV) in a clinical specimen, using a fluorescent immunoassay method.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OMI Multiplex flow immunoassay, t.Gondii, rubella and cmv.
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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
cc589741-55ac-48b8-907b-d8497c15a394
January 23, 2020
4
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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