DEVICE: VIROTROL (00847661005575)

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Device Record History
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Device Identifier (DI) Information
VIROTROL
00128B
In Commercial Distribution
00128B
BIO-RAD LABORATORIES, INC.
00847661005575
GS1

1
051624070 *Terms of Use
VIROTROL EBV (An unassayed (human) serology control.)
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
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?
60900 Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin M (IgM) 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 M (IgM) antibodies to the early antigen (EA) of Epstein-Barr virus (EBV) in a clinical specimen.
Obsolete false
49686 Epstein-Barr virus (EBV) early antigen (EA) 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 the early antigen (EA) of Epstein-Barr virus (EBV) in a clinical specimen.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
OHQ Multi-analyte controls unassayed
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes 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
No Device Sizes
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Device Record Status
02073cfe-0a35-4b01-91f5-6249feb5e63f
September 22, 2020
1
September 14, 2020
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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
No
No CLOSE

Customer Contact

[?]
+1(800)854-6737
qsd.techservice@bio-rad.com
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