Validate

Basic Information

• Brand Name: Validate
• Primary DI: 00850011135716
• Version / Model: 408re
• Catalog Number: 408re
• Company Name: Lgc Clinical Diagnostics, Inc.
• Labeler DUNS: 075886031
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-05
• Public Version: 1
• Public Version Date: 2024-09-13
• Public Version Status: New
• Public Device Record Key: 5d29a961-1649-4e19-aaa5-a7011c03a4b9

Device Description

VALIDATE Tumor Markers 2 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analytes: CYFRA 21-1 Set: Cytokeratin 19 Fragment (CYFRA 21-1). HE4 Set: Human Epididymal Protein 4 (HE4). VALIDATE Test Kits are non-automated and intended for laboratory professional use only.

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
38177	Cytokeratin 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 one or multiple cytokeratin subtype(s) in a clinical specimen.	No	Active
56657	Human epididymis protein 4 (HE4) 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 human epididymis protein 4 (HE4) ovarian cancer marker, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850011135716	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: 2 – 8 Degrees Celsius