Validate

Basic Information

• Brand Name: Validate
• Primary DI: 00859110005722
• Version / Model: 407re
• Catalog Number: 407re
• Company Name: Lgc Clinical Diagnostics, Inc.
• Labeler DUNS: 075886031
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-02
• Public Version: 2
• Public Version Date: 2022-02-24
• Public Version Status: Update
• Public Device Record Key: ca365cb6-f206-4504-a337-ef7b1b814a16

Device Description

Validate Tumor Markers 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
38173	Carcinoembryonic antigen (CEA) 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 carcinoembryonic antigen (CEA) in a clinical specimen.	No	Active
38222	Cancer antigen 15-3 (CA15-3) 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 cancer antigen 15-3 (CA15-3), a marker commonly associated with breast cancer, in a clinical specimen.	No	Active
38230	Cancer antigen 125 (CA125) 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 cancer antigen 125 (CA125), a marker commonly associated with ovarian cancer, in a clinical specimen.	No	Active
38224	Cancer antigen 19-9 (CA19-9) 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 gastrointestinal and pancreatic cancer antigen 19-9 (CA19-9) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859110005722	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