Validate

Basic Information

• Brand Name: Validate
• Primary DI: 00859110005869
• Version / Model: 507ro
• Catalog Number: 507ro
• 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: 3
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: ad282051-a58d-48ad-89a6-53d4802ae944

Device Description

Validate LP2 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
41809	Apolipoprotein A-I (Apo A1) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of apolipoprotein A-I (Apo A1) lipid in a clinical specimen.	No	Active
41813	Apolipoprotein B (Apo B) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of apolipoprotein B (Apo B) lipid in a clinical specimen.	No	Active
30214	Multiple lipid analyte IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of multiple lipid analytes [e.g., total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL)] to generate a lipid profile of a clinical specimen. Some types may also detect additional analytes (e.g., glucose, ketones, uric acid).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859110005869	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