DEVICE: DIASTAT anti-Thyroid Peroxidase (07340058410134)
Device Identifier (DI) Information
DIASTAT anti-Thyroid Peroxidase
FTPO300
In Commercial Distribution
FTPO300
Euro-Diagnostica AB
FTPO300
In Commercial Distribution
FTPO300
Euro-Diagnostica AB
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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55203 | Thyroid peroxidase antibody (anti-TPO/microsomal 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 antibodies to thyroid peroxidase [anti-TPO, also known as anti-microsomal antibody] in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis of chronic lymphocytic thyroiditis (also known as hashimoto thyroiditis).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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JZO | System, Test, Thyroid Autoantibody |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K020687 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
fbe1ffd6-571b-466e-b8c4-f1eab4f981d1
February 16, 2024
4
August 08, 2016
February 16, 2024
4
August 08, 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