Home GUDID 10860007612654 SeptiCyte RAPID [US IVD]
Primary DI 10860007612654
Brand SeptiCyte RAPID [US IVD]
Company Immunexpress Inc.
Model SB3020U
Device description Sepsis Host Response US IVD EDTA PAXgene Variant Dispenser Box
Published 2024-03-17
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name PRE Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PRE Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10860007612654 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10860007612654 10860007612654
GMDN Terms# Term, Definition table Term Definition Multiple clinical chemistry enzyme IVD, kit, enzyme fluorescence A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple clinical chemistry enzymes, using an enzyme fluorescence method. Analytes detected may include alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP).
Regulatory Flags# DUNS number 964789676 Device count 1 Kit true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860007612657 SeptiCyte RAPID [US IVD] SA3020U 2024-03-17 10860007612616 SeptiCyte RAPID SB3010U 2022-12-20 00860007612619 SeptiCyte RAPID SA3010U 2022-12-10
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00860007612657 SeptiCyte RAPID [US IVD] Immunexpress Inc. PRE 2024-03-17 10860007612616 SeptiCyte RAPID Immunexpress Inc. PRE 2022-12-20 00860007612619 SeptiCyte RAPID Immunexpress Inc. PRE 2022-12-10