DEVICE: ST AIA-PACK 25-OH Vitamin D CALIBRATOR SET (04560189213135)
Device Identifier (DI) Information
ST AIA-PACK 25-OH Vitamin D CALIBRATOR SET
N/A
In Commercial Distribution
TOSOH CORPORATION
N/A
In Commercial Distribution
TOSOH CORPORATION
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? |
---|---|---|---|---|
54474 | Multiple form 25-hydroxy Vitamin D IVD, calibrator |
A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy vitamin D in a clinical specimen.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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JIT | Calibrator, Secondary |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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
3ccb2d64-ca1d-41bc-8521-744e1e8c5ae4
April 01, 2024
4
September 24, 2016
April 01, 2024
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
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
650-615-8134
Dave.Wurtz@tosoh.com
Dave.Wurtz@tosoh.com