Home GUDID 00860007612619 SeptiCyte RAPID
Primary DI 00860007612619
Brand SeptiCyte RAPID
Company Immunexpress Inc.
Model SA3010U
Device description US IVD cartridge (+pouch)
Published 2022-12-10
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 00860007612619 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 00860007612619 00860007612619 860007612619 0860007612619
GMDN Terms# Term, Definition table Term Definition Reverse transcription reagent kit IVD A collection of reagents and other associated materials intended to be used in the synthesis of complimentary deoxyribonucleic acid (cDNA) by reverse transcription, to facilitate the amplification of target ribonucleic acid (RNA) in a clinical specimen, using a polymerase chain reaction (PCR) technique.
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 10860007612654 SeptiCyte RAPID [US IVD] SB3020U 2024-03-17 10860007612616 SeptiCyte RAPID SB3010U 2022-12-20
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 10860007612654 SeptiCyte RAPID [US IVD] Immunexpress Inc. PRE 2024-03-17 10860007612616 SeptiCyte RAPID Immunexpress Inc. PRE 2022-12-20