Solomon Commutable Quality Materials

Basic Information

• Brand Name: Solomon Commutable Quality Materials
• Primary DI: 00850083817039
• Version / Model: 20001LRCK
• Catalog Number: 20001LRCK
• Company Name: Solomon Park Research Laboratories, Inc.
• Labeler DUNS: 943785295
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-06
• Public Version: 1
• Public Version Date: 2026-04-14
• Public Version Status: New
• Public Device Record Key: 8998bf32-2999-420b-9880-004b5af44682

Device Description

LRC - Lipid Reference value Control Kit, 3 level Contains 3 vials,1 0.6mL vial of each: 00850038317008 - Low 00850083817015 - High 00850083817022 - Cal&QC

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47868	Multiple-type clinical chemistry analyte profile IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850083817039	GS1
Package	00850083817046	GS1	Box	27	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	1.8	Milliliter
Device Size Text, specify			3 vials

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -85 – -65 Degrees Celsius