DEVICE: Anti-Gliadin (GAF-3X) ELISA (IgA) (04049016035930)
Device Identifier (DI) Information
Anti-Gliadin (GAF-3X) ELISA (IgA)
EV 3011-9601 A
In Commercial Distribution
EUROIMMUN Medizinische Labordiagnostika AG
EV 3011-9601 A
In Commercial Distribution
EUROIMMUN Medizinische Labordiagnostika AG
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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54947 | Gliadin antibody IVD, kit, enzyme immunoassay (EIA) |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-gliadin antibodies in a clinical specimen, using an enzyme immunoassay (EIA) method. This test is intended to be used as an aid in the diagnosis of Coeliac disease.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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MST | Antibodies, Gliadin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K083052 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
ac6af2bf-1c04-423b-90fa-4adfdd7892d4
June 10, 2022
4
September 24, 2016
June 10, 2022
4
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined