DEVICE: EBV IgG Control (B110EBG50200)

Device Identifier (DI) Information

EBV IgG Control
EBG-5020
In Commercial Distribution
EBG-5020
MBL Bion
B110EBG50200
HIBCC

1
024824641 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Epstein-Barr virus (EBV) VCA 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 viral capsid antigen (VCA) of Epstein-Barr virus (EBV) in a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
LJN Antibody Igm, If, Epstein-Barr Virus
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K893240 000
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
No Device Sizes
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Device Record Status

94ef2e7d-98de-428f-9820-861b4ad9ddb6
July 06, 2018
3
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
No
No CLOSE

Customer Contact

[?]
847-544-5044
bion@mblintl.com
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