DEVICE: LIAISON® Biotrin Parvovirus B19 IgG Plus (08056771104029)

Device Identifier (DI) Information

LIAISON® Biotrin Parvovirus B19 IgG Plus
311550
In Commercial Distribution

DIASORIN SPA
08056771104029
GS1

1
630822989 *Terms of Use
Italy manufactured kit.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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?
63423 Parvovirus B19 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent 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 Parvovirus B19 in a clinical specimen, using a chemiluminescent immunoassay method.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MYL Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P220034 000
No CLOSE

Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

93f0b88d-904d-4676-89db-b7792d8d9762
April 16, 2024
1
April 08, 2024
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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