Home GUDID 00860014139307 Color Saliva Collection Kit
Primary DI 00860014139307
Brand Color Saliva Collection Kit
Company Color Diagnostics, LLC
Model 1.0
Published 2025-06-09
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name OYJ Dna Specimen Collection, Saliva
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OYJ Dna Specimen Collection, Saliva Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860014139307 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860014139307 00860014139307 860014139307 0860014139307
GMDN Terms# Term, Definition table Term Definition Specimen stabilization reagent IVD A substance or reactant intended to be used alone or in combination with other IVDs to prevent degradation of sensitive analytes (e.g., hormones, proteins, peptides and/or nucleic acids) in a clinical specimen during transportation, storage or processing. A stabilizer is typically a solvent, antioxidant or an enzyme inhibitor.
Regulatory Flags# DUNS number 118772507 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860014139314 Color Urine Collection Kit 1.0 2025-06-09 00860014139321 Color Blood Collection Kit (Upper Arm) 1.0 2025-06-09 00860014139338 Color Stool Collection Kit 1.0 2025-06-09
Other Devices Sharing Product Codes#