Home GUDID 00859410006153 Salimetrics
Primary DI 00859410006153
Brand Salimetrics
Company SALIMETRICS, LLC
Model N/A
Catalog number 1-2812
Device description High Sensitivity Salivary Estriol Enzyme Immunoassay Kit
Published 2022-08-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name PEJ Salivary Estriol Test
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PEJ Salivary Estriol Test Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00859410006153 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 00859410006153 00859410006153 859410006153 0859410006153
GMDN Terms# Term, Definition table Term Definition Free estriol (oestriol) IVD, kit, enzyme immunoassay (EIA) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free estriol (oestriol) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically measured in maternal blood, urine or saliva as a marker of foetal health, gestational age, or fetoplacental distress typically in pregnancies complicated by diabetes, hypertension, or prolonged gestation.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 084843064 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00859410006160 Salimetrics SALIMETRICS, LLC PEJ 2022-08-23