DEVICE: BioPlex 2200 (00847865000741)

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Device Record History
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Device Identifier (DI) Information
BioPlex 2200
6632430
In Commercial Distribution
6632430
BIO-RAD LABORATORIES, INC.
00847865000741
GS1

1
884513334 *Terms of Use
MMRV IgG Control Set
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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?
49293 Measles virus immunoglobulin G (IgG) antibody IVD, control
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Measles virus in a clinical specimen.
Active false
42140 Rubella virus immunoglobulin G (IgG) antibody IVD, control
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Rubella virus in a clinical specimen.
Active false
49336 Mumps virus immunoglobulin G (IgG) antibody IVD, control
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Mumps virus in a clinical specimen.
Active false
49625 Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, control
A material which is used to verify the performance of an assay 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LJB Enzyme linked immunoabsorbent assay, rubeola IgG
LJY ENZYME LINKED IMMUNOABSORBENT ASSAY, MUMPS VIRUS
OPL Multiplex immunoassay for measles virus, mumps virus, rubella and varicella zoster virus
LFY ENZYME LINKED IMMUNOABSORBENT ASSAY, VARICELLA-ZOSTER
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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
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 1.5 Milliliter
Device Size Text, specify: 4 Vials
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Device Record Status
b0215508-2d4c-47e2-a1cd-190a89a7bbbd
July 29, 2021
6
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
Yes
Yes
No CLOSE

Customer Contact

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