Autogenomics Inc

FDA Filings

This page includes the latest FDA filings for Autogenomics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3005406097
FEI Number3005406097
NameAUTOGENOMICS, INCORPORATED
Owner & OperatorPrescient Medicine
Contact Address1600 Faraday Avenue
Carlsbad CA 92008 US
Official Correspondent
  • Evelyn Lopez
  • 01-760-4772248-345
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1600 Faraday Avenue
Carlsbad, CA 92008 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only

FDA Filings

Device
Company
DeviceDate
AUTOGENOMICS, INC
 AvertD™ Buccal Sample Collection Kit 12-0610-012024-06-10
AUTOGENOMICS, INC
 AvertD™ BioFilmChip Microarray Magazine 03-1560-012024-06-10
AUTOGENOMICS, INC
 AvertD™ Intellipac Reagent Module 03-2560-012024-06-10
AUTOGENOMICS, INC
 AvertD™ Amplification Mix 03-3560-012024-06-10
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI FMF2019-12-19
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI Candida Vaginitis QUAD2019-12-19
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI BRAF Assay2019-12-19
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI Urogen PLUS QUAD2019-12-19
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI Buccal Sample Collection Kit2019-12-19
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI KRAS Assay2019-12-19
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI FLUA-SH1N12019-12-19
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI MTHFR Assay2019-12-19
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI CYP450 2C9-VKORC1 Assay2019-12-19
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI RVP Plus Assay2019-12-19
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI CFTR-31 Assay2019-12-19
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI UGT1A1 Assay2019-12-19
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI CYP4502D6BC Assay2019-12-19
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI CYP2C19+ Assay2019-12-19
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI PLUS Analyzer2019-12-19
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI High Throughput System2019-12-19
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI Factor II-V & MTHFR Assay2019-12-19
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI Bacterial Vaginosis QUAD2019-12-19
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI HPV QUAD2019-12-19
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI HPV HR QUAD2019-12-19
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI HPV Genotyping2019-12-19
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI H.pylori QUAD2019-12-19
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI CYP2C19 Assay2019-11-18
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI CYP2C19 Assay2019-11-18
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI Warfarin Assay2019-11-18
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI Warfarin Assay2019-11-18
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI Warfarin Assay2019-11-18
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI Factor V Leiden Assay2019-11-18
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI FACTOR II-V Assay2019-11-18
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI FACTOR II Assay2019-11-18
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI Factor V Leiden Assay2019-11-18
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI FACTOR II-V Assay2019-11-18
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI FACTOR II Assay2019-11-18
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI Factor V Leiden Assay2019-11-18
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI FACTOR II-V Assay2019-11-18
AUTOGENOMICS, INCORPORATED [Prescient Medicine]
INFINITI FACTOR II Assay2019-11-18
AUTOGENOMICS, INC
 INFINITI® Warfarin Amplification Mix 03-3140-012019-10-31
AUTOGENOMICS, INC
 INFINITI® Warfarin Intellipac® Reagent Module 03-2140-012019-10-31
AUTOGENOMICS, INC
 INFINITI® Warfarin BioFilmChip® Microarray Magazine 03-1140-012019-10-31
AUTOGENOMICS, INC
 INFINITI® CYP2C19 Amplification Mix 03-3220-012019-10-31
AUTOGENOMICS, INC
 INFINITI® CYP2C19 Intellipac® Reagent Module 03-2220-012019-10-31
AUTOGENOMICS, INC
 INFINITI® CYP2C19 BioFilmChip® Microarray Magazine 03-1220-012019-10-31
AUTOGENOMICS, INC
 INFINITI® Factor II-V Leiden Amplification Mix 01-3050-012019-10-31
AUTOGENOMICS, INC
 INFINITI® Factor II-V Leiden Intellipac® Reagent Module 01-2050-012019-10-31
AUTOGENOMICS, INC
 INFINITI® Factor II-V Leiden BioFilmChip® Microarray Magazine 01-1050-012019-10-31
AUTOGENOMICS, INC
 INFINITI® Factor V Leiden Amplification Mix 01-3030-012019-10-31
AUTOGENOMICS, INC
 INFINITI® Factor V Leiden Intellipac® Reagent Module 01-2030-012019-10-31
AUTOGENOMICS, INC
 INFINITI® Factor V Leiden BioFilmChip® Microarray Magazine 01-1030-012019-10-31
AUTOGENOMICS, INC
 INFINITI® Factor II Amplification Mix 01-3020-012019-10-31
AUTOGENOMICS, INC
 INFINITI® Factor II Intellipac® Reagent Module 01-2020-012019-10-31
AUTOGENOMICS, INC
 INFINITI® Factor II BioFilmChip® Microarray Magazine 01-1020-012019-10-31
AUTOGENOMICS, INC
 INFINITI® High Throughput System (HTS) INCUBATOR 10-0070-992019-10-31
AUTOGENOMICS, INC
 INFINITI® High Throughput System (HTS) PROCESSOR 10-0060-992019-10-31
AUTOGENOMICS, INC
 INFINITI® High Throughput System (HTS) ACE ANALYZER 10-0030-992019-10-31
AUTOGENOMICS, INC
 INFINITI® PLUS ANALYZER 10-0020-992019-10-31
AUTOGENOMICS, INCORPORATED
INFINITI CYP2C19 ASSAY2010-10-25
AUTOGENOMICS, INCORPORATED
INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN2008-01-23
AUTOGENOMICS, INC
INFINITI SYSTEM2007-02-07

Related Finance Registrations
NCAGE Code4VEN8AUTOGENOMICS, INC
CAGE Code4VEN8AUTOGENOMICS, INC
S.A.M. Registration4VEN8 [27914535]AUTOGENOMICS, INC
DUNS027914535AutoGenomics, Inc
DUNS027914535AutoGenomics, Inc.
SEC0001132919AUTOGENOMICS INC
SEC0001439210AutoGenomics, Inc. of DELAWARE
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