autogenomics.comINFINITI CYP2C19 ASSAY
AUTOGENOMICS, INCORPORATED
AUTOGENOMICS, INCORPORATED
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005406097 | 3005406097 | AUTOGENOMICS, INCORPORATED | 1 | N | 2026-01-01 | 1600 Faraday Avenue Carlsbad CA US 92008 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10850009370195 | AvertD™ Amplification Mix - 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. | 760-477-2248 | techsupport@autogenomics.com |
| 10850009370201 | AvertD™ Intellipac Reagent Module - The Intellipac 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. | 760-477-2248 | techsupport@autogenomics.com |
| 10850009370218 | AvertD™ BioFilmChip Microarray Magazine - The BioFilmChip Microarray consists of a polyester film coated with proprietary multi-layer components designed for DNA analysis as part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA. | 760-477-2248 | techsupport@autogenomics.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 235469 | 1969516896 | P230032 | AvertD and AvertD Buccal Sample Collection Kit | QZH | 2023-12-19 |
| 235469 | 2065620866 | K101683 | INFINITI CYP2C19 ASSAY | NTI | 2010-10-25 |
| 235469 | 1767741520 | K073014 | INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN | ODW | 2008-01-23 |
| 235469 | 1928231998 | K060564 | INFINITI SYSTEM | NPQ | 2007-02-07 |
| 235469 | 1017884193 | ||||
| 235469 | 1190522199 | ||||
| 235469 | 1326827501 | ||||
| 235469 | 1383834312 | ||||
| 235469 | 1573352720 | ||||
| 235469 | 1577099203 | ||||
| 235469 | 1684716509 | ||||
| 235469 | 1820173556 | ||||
| 235469 | 1868355152 | ||||
| 235469 | 1901599605 | ||||
| 235469 | 2072286200 | ||||
| 235469 | 1468511301 | ||||
| 235469 | 1556006268 | ||||
| 235469 | 1773067275 | ||||
| 235469 | 1790562477 | ||||
| 235469 | 1816208738 | ||||
| 235469 | 2028002913 |
Product Codes Associated With Registrations#
PMN#
INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN
AUTOGENOMICS, INCORPORATED
INFINITI SYSTEM
AUTOGENOMICS, INC
GUDID#
AvertD™ (96) PE Mix - 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.
2024-11-18
AvertD™ (96) AMP Mix - 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.
2024-11-18
AvertD™ (96) Tube - The Tube consists of BioFilmChip Microarray made of a polyester film coated with proprietary multi-layer components designed for DNA analysis as part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
2024-11-18
AvertD™ (96) PE Mix - 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.
2024-11-18
AvertD™ (96) AMP Mix - 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.
2024-11-18
AvertD™ Amplification Mix - 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.
2024-05-31
AvertD™ Intellipac Reagent Module - The Intellipac 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.
2024-05-31
AvertD™ BioFilmChip Microarray Magazine - The BioFilmChip Microarray consists of a polyester film coated with proprietary multi-layer components designed for DNA analysis as part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
2024-05-31
AvertD™ Buccal Sample Collection Kit - Buccal Sample Collection Kit for use with AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
2024-05-31
INFINITI® PLUS ANALYZER - Instrumentation For Clinical Multiplex Test Systems
2019-10-23
INFINITI® High Throughput System (HTS) ACE ANALYZER - Instrumentation For Clinical Multiplex Test Systems
2019-10-23
INFINITI® High Throughput System (HTS) PROCESSOR - Instrumentation For Clinical Multiplex Test Systems
2019-10-23
INFINITI® High Throughput System (HTS) INCUBATOR - Instrumentation For Clinical Multiplex Test Systems
2019-10-23
INFINITI® Factor II BioFilmChip® Microarray Magazine - Genotyping system for the detection of Factor II (Prothrombin) G20210A mutations.
2019-10-23
INFINITI® Factor II Intellipac® Reagent Module - Genotyping system for the detection of Factor II (Prothrombin) G20210A mutation
2019-10-23
INFINITI® Factor II Amplification Mix - Genotyping system for the detection of Factor II (Prothrombin) G20210A mutations.
2019-10-23
INFINITI® Factor V Leiden BioFilmChip® Microarray Magazine - Genotyping system for the detection of the Factor V Leiden G1691A mutation
2019-10-23
INFINITI® Factor V Leiden Intellipac® Reagent Module - Genotyping system for the detection of the Factor V Leiden G1691A mutation
2019-10-23
INFINITI® Factor V Leiden Amplification Mix - Genotyping systme for the detection of the Factor V Leiden G1691A mutation
2019-10-23
INFINITI® Factor II-V Leiden BioFilmChip® Microarray Magazine - Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations
2019-10-23
INFINITI® Factor II-V Leiden Intellipac® Reagent Module - Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations
2019-10-23
INFINITI® Factor II-V Leiden Amplification Mix - Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations
2019-10-23
INFINITI® CYP2C19 BioFilmChip® Microarray Magazine - CYP2C19 drug metabolyzing enzyme genotyping system
2019-10-23
INFINITI® CYP2C19 Intellipac® Reagent Module - CYP2C19 drug metabolyzing enzyme genotyping system
2019-10-23
INFINITI® CYP2C19 Amplification Mix - CYP2C19 drug metabolyzing enzyme genotyping system
2019-10-23
INFINITI® Warfarin BioFilmChip® Microarray Magazine - CYP450 2C9 drug metabolizing enzyme and VKORC1 genotyping system
2019-10-23
INFINITI® Warfarin Intellipac® Reagent Module - CYP450 2C9 drug metabolizing enzyme and VKORC1 genotyping system
2019-10-23
INFINITI® Warfarin Amplification Mix - CYP450 2C9 drug metabolizing enzyme and VKORC1 genotyping system
2019-10-23