Data / Medical devices / United States / Autogenomics, Incorporated
Autogenomics, Incorporated: FDA-registered device maker in Carlsbad, CA, United States, 3 510(k) clearances and 1 PMA approval
Autogenomics, Incorporated is registered with the FDA (registration 3005406097) in Carlsbad, CA, United States. It lists 10 device types. The FDA files 3 510(k) clearances and 1 PMA approval under its listings, the newest dated December 19, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005406097
- Address
- 1600 Faraday Avenue, Carlsbad, CA, United States, 92008
- Owner or operator
- Prescient Medicine Holdings Inc DBA SOLVD Health (10061771)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- November 18, 2019
- Registered through
- 2026
- Brand names listed
- AvertD and AvertD Buccal Sample Collection Kit, INFINITI Buccal Sample Collection Kit, INFINITI CYP2C19 Assay, INFINITI CYP2C19+ Assay, INFINITI CYP450 2C9-VKORC1 Assay, INFINITI CYP4502D6BC Assay, INFINITI FACTOR II Assay, INFINITI FACTOR II-V Assay and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System | ODW | 2 | Manufacturer | accessdata.fda.gov |
| Dna Specimen Collection, Saliva | OYJ | 2 | Manufacturer for export | accessdata.fda.gov |
| Drug Metabolizing Enzyme Genotyping Systems | NTI | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Instrumentation For Clinical Multiplex Test Systems | NSU | 2 | Manufacturer | accessdata.fda.gov |
| Kit, Dna Detection, Human Papillomavirus | MAQ | 3 | Manufacturer for export | accessdata.fda.gov |
| Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit | QZH | 3 | Manufacturer | accessdata.fda.gov |
| Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr | OMM | 2 | Manufacturer for export | accessdata.fda.gov |
| Test, Factor Ii G20210a Mutations, Genomic Dna Pcr | NPR | 2 | Manufacturer | accessdata.fda.gov |
| Test, Factor V Leiden Mutations, Genomic Dna Pcr | NPQ | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System | ODV | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 25, 2010 | K101683 | INFINITI CYP2C19 ASSAY | NTI | Substantially Equivalent | Autogenomics, Incorporated | accessdata.fda.gov |
| January 23, 2008 | K073014 | INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN | ODW | Substantially Equivalent | Autogenomics, Incorporated | accessdata.fda.gov |
| February 7, 2007 | K060564 | INFINITI SYSTEM | NPQ | Substantially Equivalent | AutoGenomics, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 19, 2023 | P230032 | AvertD and AvertD Buccal Sample Collection Kit | QZH | 5 | May 20, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Test, Factor V Leiden Mutations, Genomic Dna Pcr
- All makers of Instrumentation For Clinical Multiplex Test Systems
- All makers of Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
- All makers of Drug Metabolizing Enzyme Genotyping Systems
Updated May 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.