DEVICE: AIA-PACK TSH 3rd-Gen CALIBRATOR SET (04560189211254)

Device Identifier (DI) Information

AIA-PACK TSH 3rd-Gen CALIBRATOR SET
N/A
In Commercial Distribution

TOSOH CORPORATION
04560189211254
GS1

1
690571724 *Terms of Use
No description.
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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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
38272 Thyroid stimulating hormone (TSH) IVD, calibrator
A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of thyroid stimulating hormone (TSH) in a clinical specimen.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JIS Calibrator, Primary
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

bd5f1341-e83b-45b1-9d38-69a3f0821a62
February 21, 2024
3
September 24, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
650-615-8134
Dave.Wurtz@tosoh.com
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