Home GUDID 00884999050808 Alinity m
Primary DI 00884999050808
Brand Alinity m
Company ABBOTT MOLECULAR INC.
Model 08N47-03B
Catalog number 08N47-03B
Device description Alinity m HBV Application Specification File
Published 2023-08-30
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name MKT Hepatitis Viral B Dna Detection
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MKT Hepatitis Viral B Dna Detection Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00884999050808 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 00884999050808 00884999050808 884999050808 0884999050808
GMDN Terms# Term, Definition table Term Definition Laboratory instrument/analyser application software IVD An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).
Regulatory Flags# DUNS number 878263359 Device count 1 DM exempt true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00875197006414 cobas® HBV Roche Molecular Systems, Inc. MKT 2021-12-10 00884999047754 Alinity m ABBOTT MOLECULAR INC. MKT 2020-09-23 00884999047808 Alinity m ABBOTT MOLECULAR INC. MKT 2020-09-23 00884999047815 Alinity m ABBOTT MOLECULAR INC. MKT 2020-09-23 00884999048645 Alinity m ABBOTT MOLECULAR INC. MKT 2020-09-23 15420045506749 Aptima® Hologic, Inc. MKT 2018-01-30 15420045506756 Aptima® Hologic, Inc. MKT 2018-01-30 15420045506763 Aptima® Hologic, Inc. MKT 2018-01-30 15420045506770 Aptima® Hologic, Inc. MKT 2018-01-30 00884999042667 RealTime ABBOTT MOLECULAR INC. MKT 2016-07-28 00875197004717 cobas® HIV1 Quantitative nucleic acid test for use on the cobas® 68 88 Systems Roche Diagnostics GmbH MKT 2016-02-26 00875197004885 cobas® HBV Quantitative nucleic acid test for use on the cobas® 6800/8800 System Roche Diagnostics GmbH MKT 2015-12-04 00884999003057 RealTime ABBOTT MOLECULAR INC. MKT 2014-11-20 00884999003064 RealTime ABBOTT MOLECULAR INC. MKT 2014-11-20 00884999003071 RealTime ABBOTT MOLECULAR INC. MKT 2014-11-20 00884999037762 RealTime ABBOTT MOLECULAR INC. MKT 2014-11-20 00884999038462 RealTime ABBOTT MOLECULAR INC. MKT 2014-11-20 04015630936557 DOCKING STATION SHORT Roche Molecular Systems, Inc. MKT 2014-09-19 04038377020556 High Pure System Viral Nucleic Acid Kit Roche Molecular Systems, Inc. MKT 2014-09-10 00875197002003 COBAS® TaqMan® HBV Test, For Use With The High Pure System Roche Molecular Systems, Inc. MKT 2014-09-10 00875197002034 COBAS® AmpliPrep / COBAS® TaqMan® Wash Reagent Roche Molecular Systems, Inc. MKT 2014-09-10 00875197002706 COBAS® AmpliPrep / COBAS® TaqMan® HBV Test, v2.0 Roche Molecular Systems, Inc. MKT 2014-09-09
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