DEVICE: GSP Neonatal Thyroxine (T4) kit (06438147312139)
Device Identifier (DI) Information
GSP Neonatal Thyroxine (T4) kit
3302-001U
In Commercial Distribution
3302-001U
Wallac Oy
3302-001U
In Commercial Distribution
3302-001U
Wallac Oy
For the quantitative determination of thyroxine (T4) in dried blood.
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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59222 | Neonatal thyroxine (neonatal T4) IVD, kit, fluorescent immunoassay |
A collection of reagents and other associated materials intended to be used for the quantitative measurement of neonatal thyroxine (neonatal T4) 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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KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K103484 | 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
90d5b38f-380b-44bd-9305-a32052091956
July 06, 2018
3
January 12, 2016
July 06, 2018
3
January 12, 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
[?]
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