VALIDATE

Basic Information

• Brand Name: VALIDATE
• Primary DI: 00850011135563
• Version / Model: 1003ro
• Company Name: Lgc Clinical Diagnostics, Inc.
• Labeler DUNS: 075886031
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-13
• Public Version: 1
• Public Version Date: 2024-12-23
• Public Version Status: New
• Public Device Record Key: b4b3512a-4e8e-4f46-a7fb-76d52e391f98

Device Description

Validate LCMS Steroids Test Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active
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.	No	Active
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.	No	Active
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.	No	Active
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.	No	Active
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.	No	Active
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.	No	Active
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.	No	Active
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.	No	Active
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850011135563	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – -10 Degrees Celsius