DEVICE: Anti-Echinococcus granulosus IFA (IgG) (04049016055655)

Device Identifier (DI) Information

Anti-Echinococcus granulosus IFA (IgG)
FI 2320-2005 G
In Commercial Distribution

EUROIMMUN Medizinische Labordiagnostika AG
04049016055655
GS1

1
322209263 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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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
Echinococcus granulosus immunoglobulin G (IgG) 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 G (IgG) antibodies to Echinococcus granulosus in a clinical specimen using a fluorescent immunoassay method. The assay is designed to detect infection with Echinococcus granulosus, the parasitic tapeworm associated with hydatid disease.
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FDA Product Code

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Product Code Product Code Name
GPD Antigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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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

73c897be-1ced-4914-a160-5f2c7ab1fe79
March 29, 2018
2
September 24, 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
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No CLOSE

Customer Contact

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No Customer Contact currently defined
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