DEVICE: IFA: Oesophagus (Monkey) IgA (04049016048596)
Device Identifier (DI) Information
IFA: Oesophagus (Monkey) IgA
FA 1911-1003 A
Not in Commercial Distribution
EUROIMMUN Medizinische Labordiagnostika AG
FA 1911-1003 A
Not in Commercial Distribution
EUROIMMUN Medizinische Labordiagnostika AG
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
54905 | Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-endomysial antibodies (anti-EMA) in a clinical specimen, using a fluorescent immunoassay method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K061408 | 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
fa03550d-e22b-460d-bfd0-b1fb2833e1d0
November 22, 2022
4
September 24, 2016
November 22, 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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
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