AUTOGENOMICS, INCORPORATED

FDA Device Registration & Listing · Carlsbad, CA, US · Registration 3005406097

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005406097
FEI Number
3005406097
Entity Name
AUTOGENOMICS, INCORPORATED
City/State/Country
Carlsbad, CA, US
Establishment Address
1600 Faraday Avenue, Carlsbad, CA 92008, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
Prescient Medicine Holdings Inc DBA SOLVD Health (Owner Number: 10061771)
Owner / Operator Contact Address
1600 Faraday Avenue, Carlsbad, CA 92008, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

INFINITI CYP2C19+ Assay INFINITI CYP4502D6BC Assay INFINITI UGT1A1 Assay INFINITI High Throughput System INFINITI PLUS Analyzer INFINITI MTHFR Assay INFINITI Warfarin Assay INFINITI CYP450 2C9-VKORC1 Assay

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NTI Drug Metabolizing Enzyme Genotyping Systems Clinical Toxicology Class 2 862.3360 2019-12-19
NSU Instrumentation For Clinical Multiplex Test Systems Clinical Chemistry Class 2 862.2570 2019-12-19
OMM Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr Hematology Class 2 864.7280 2019-12-19
ODW Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System Clinical Toxicology Class 2 862.3360 2019-11-18
ODV Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System Hematology Class 2 864.7750 2019-11-18
NSU Instrumentation For Clinical Multiplex Test Systems Clinical Chemistry Class 2 862.2570 2019-11-18
MAQ Kit, Dna Detection, Human Papillomavirus Unknown Class 3 N/A 2019-12-19
ODV Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System Hematology Class 2 864.7750 2019-12-19

Official Correspondent

Heather Carbaugh

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Prescient Medicine Holdings Inc DBA SOLVD Health
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2018 Hologic, Inc 2
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005406097. Last updated year: 2026. Please use registration number 3005406097 when referencing this establishment in official correspondence.
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