DEVICE: EBV-VCA IgM Test System, 120 Tests (B110EBM1200)

Device Identifier (DI) Information

EBV-VCA IgM Test System, 120 Tests
EBM-120
In Commercial Distribution
EBM-120
MBL Bion
B110EBM1200
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
Yes
No
No

GMDN

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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 M (IgM) 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 M (IgM) antibodies to the viral capsid antigen (VCA) of Epstein-Barr virus (EBV) in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever.
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FDA Product Code

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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
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

effcec96-c99c-4c20-ae9a-a6932348f76c
July 06, 2018
3
September 12, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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847-544-5044
bion@mblintl.com
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