DEVICE: AIA-PACK ACTH Control Set (04560189212558)

Device Identifier (DI) Information

AIA-PACK ACTH Control Set
N/A
In Commercial Distribution

TOSOH CORPORATION
04560189212558
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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Familial glucocorticoid deficiency (FGD) IVD, control A material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict familial glucocorticoid deficiency (FGD), an inborn genetic disorder associated with adrenal unresponsiveness to the adrenocorticotropic hormone (ACTH) and hypopituitarism due to mutations in the gene encoding melanocortin-2 receptor (MC2R).
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FDA Product Code

[?]
Product Code Product Code Name
JJY Multi-Analyte Controls, All Kinds (Assayed)
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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

95b5ef9c-3d40-4317-bdd0-eb66891fed44
March 29, 2018
2
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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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

[?]
614-317-1909
Levent.durukan@tosoh.com
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