Home GUDID 30850009370243 AvertD™ (96) PE Mix
Primary DI 30850009370243
Brand AvertD™ (96) PE Mix
Company AUTOGENOMICS, INC
Model 03-6560-01
Catalog number 03-6560-01
Device description The PE Mix Reagent Module acts as a communication link with up to four reservoirs that house the test reagents as the Primer Extension Reaction is part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
Published 2024-11-18
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name QZH Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QZH Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30850009370243 Package GS1 4 In Commercial Distribution 10850009370249 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 30850009370243 30850009370243 10850009370249 10850009370249
GMDN Terms# Term, Definition table Term Definition Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT) A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to determine the risk of developing opioid use disorder (OUD) based on multiple disease-associated genotypes, using a nucleic acid technique (NAT). These genotypes may include, but are not limited to, variants of the methylenetetrahydrofolate reductase (MTHFR), mu-opioid receptor, galanin (GAL) and ABCB1 genes.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature -30 Degrees Celsius -15 Degrees Celsius
Regulatory Flags# DUNS number 027914535 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10850009370249 AvertD™ (96) PE Mix 03-6560-01 03-6560-01 2024-11-18 10850009370256 AvertD™ (96) AMP Mix 03-7560-01 03-7560-01 2024-11-18 10850009370232 AvertD™ (96) Tube 03-5560-01 03-5560-01 2024-11-18 30850009370250 AvertD™ (96) AMP Mix 03-7560-01 03-7560-01 2024-11-18 10850009370195 AvertD™ Amplification Mix 03-3560-01 03-3560-01 2024-05-31 10850009370201 AvertD™ Intellipac Reagent Module 03-2560-01 03-2560-01 2024-05-31 10850009370218 AvertD™ BioFilmChip Microarray Magazine 03-1560-01 03-1560-01 2024-05-31 10850009370225 AvertD™ Buccal Sample Collection Kit 12-0610-01 12-0610-01 2024-05-31 00850009370006 INFINITI® PLUS ANALYZER 10-0020-99 10-0020-99 2019-10-23 00850009370013 INFINITI® High Throughput System (HTS) ACE ANALYZER 10-0030-99 10-0030-99 2019-10-23 00850009370020 INFINITI® High Throughput System (HTS) PROCESSOR 10-0060-99 10-0060-99 2019-10-23 00850009370037 INFINITI® High Throughput System (HTS) INCUBATOR 10-0070-99 10-0070-99 2019-10-23 00850009370044 INFINITI® Factor II BioFilmChip® Microarray Magazine 01-1020-01 01-1020-01 2019-10-23 00850009370051 INFINITI® Factor II Intellipac® Reagent Module 01-2020-01 01-2020-01 2019-10-23 00850009370068 INFINITI® Factor II Amplification Mix 01-3020-01 01-3020-01 2019-10-23 00850009370075 INFINITI® Factor V Leiden BioFilmChip® Microarray Magazine 01-1030-01 01-1030-01 2019-10-23 00850009370082 INFINITI® Factor V Leiden Intellipac® Reagent Module 01-2030-01 01-2030-01 2019-10-23 00850009370099 INFINITI® Factor V Leiden Amplification Mix 01-3030-01 01-3030-01 2019-10-23 00850009370105 INFINITI® Factor II-V Leiden BioFilmChip® Microarray Magazine 01-1050-01 01-1050-01 2019-10-23 00850009370112 INFINITI® Factor II-V Leiden Intellipac® Reagent Module 01-2050-01 01-2050-01 2019-10-23
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10850009370249 AvertD™ (96) PE Mix AUTOGENOMICS, INC QZH 2024-11-18 10850009370256 AvertD™ (96) AMP Mix AUTOGENOMICS, INC QZH 2024-11-18 10850009370232 AvertD™ (96) Tube AUTOGENOMICS, INC QZH 2024-11-18 30850009370250 AvertD™ (96) AMP Mix AUTOGENOMICS, INC QZH 2024-11-18 10850009370195 AvertD™ Amplification Mix AUTOGENOMICS, INC QZH 2024-05-31 10850009370201 AvertD™ Intellipac Reagent Module AUTOGENOMICS, INC QZH 2024-05-31 10850009370218 AvertD™ BioFilmChip Microarray Magazine AUTOGENOMICS, INC QZH 2024-05-31 10850009370225 AvertD™ Buccal Sample Collection Kit AUTOGENOMICS, INC QZH 2024-05-31
autogenomics.com