Validate

Basic Information

• Brand Name: Validate
• Primary DI: 00859110005814
• Version / Model: 502re
• Catalog Number: 502re
• Company Name: Lgc Clinical Diagnostics, Inc.
• Labeler DUNS: 075886031
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-15
• Public Version: 3
• Public Version Date: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: afb76d7e-4759-4aa3-985e-138b54e5d2b7

Device Description

Validate Fertility 1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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
58380	Total 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 total testosterone in a clinical specimen.	No	Active
54338	Prolactin 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 prolactin in a clinical specimen.	No	Active
38247	Luteinizing hormone (LH) 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 luteinizing hormone (LH) in a clinical specimen.	No	Active
54021	Human chorionic gonadotropin beta-subunit (beta-HCG)/follicle stimulating hormone (FSH) IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or semi-quantitative detection of beta-subunit human chorionic gonadotropin (beta-HCG) and follicle stimulating hormone (FSH) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859110005814	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			2 tests

Storage Conditions

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