DEVICE: VALIDATE (00850011135563)

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Device Identifier (DI) Information
VALIDATE
1003ro
In Commercial Distribution

Lgc Clinical Diagnostics, Inc.
00850011135563
GS1

1
075886031 *Terms of Use
Validate LCMS Steroids Test Kit
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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?
54183 Free testosterone IVD, control
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of free testosterone in a clinical specimen.
Active false
45828 Aldosterone IVD, control
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of aldosterone in a clinical specimen.
Active false
41780 Androstenedione IVD, control
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of androstenedione in a clinical specimen.
Active false
63852 Free cortisol/cortisone IVD, control
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of both free cortisol and free cortisone in a clinical specimen.
Active false
41897 Dehydroepiandrosterone (DHEA) IVD, control
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of dehydroepiandrosterone (DHEA) in a clinical specimen.
Active false
54141 Dehydroepiandrosterone sulfate (DHEAS) IVD, control
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of dehydroepiandrosterone sulfate (DHEAS) in a clinical specimen.
Active false
54145 Dihydrotestosterone IVD, control
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of dihydrotestosterone (DHT) in a clinical specimen.
Active false
38248 Estradiol (oestradiol) (E2) IVD, control
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of the estrogen (oestrogen) hormone estradiol (oestradiol) in a clinical specimen.
Active false
45709 17-Hydroxyprogesterone IVD, control
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of 17-hydroxyprogesterone in a clinical specimen.
Active false
54326 Progesterone IVD, control
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of progesterone in a clinical specimen.
Active false
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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 -25 and -10 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
b4b3512a-4e8e-4f46-a7fb-76d52e391f98
December 23, 2024
1
December 13, 2024
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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

[?]
No Customer Contact currently defined
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