Home GUDID 10850009370256 AvertD™ (96) AMP Mix
Primary DI 10850009370256
Brand AvertD™ (96) AMP Mix
Company AUTOGENOMICS, INC
Model 03-7560-01
Catalog number 03-7560-01
Device description The Amplification Mix provides the reagent for the PCR amplification of the DNA sample as 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 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 30850009370250 Package GS1 4 In Commercial Distribution 10850009370256 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 30850009370250 30850009370250 10850009370256 10850009370256
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 Lot or batch true Expiration date on label true 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 10850009370232 AvertD™ (96) Tube 03-5560-01 03-5560-01 2024-11-18 30850009370243 AvertD™ (96) PE Mix 03-6560-01 03-6560-01 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 10850009370232 AvertD™ (96) Tube AUTOGENOMICS, INC QZH 2024-11-18 30850009370243 AvertD™ (96) PE Mix 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
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