Autogenomics, Inc
Country not established
Autogenomics, Inc is a medical device manufacturer, with 28 devices listed in FDA GUDID, FDA 510(k) and FDA PMA (FDA Class II and III) as of 14 Nov 2026.
- Devices
- 28
Registry facts
- Registries
- FDA GUDID 26
- FDA 510(k) 1
- FDA PMA 1
- Device classes
- FDA Class II 20
- FDA Class III 8
- Identifiers
- DUNS 027914535
What Autogenomics, Inc makes
Autogenomics, Inc. manufactures in vitro diagnostic (IVD) devices for opioid use disorder (OUD) genotyping, including nucleic acid-based testing kits and specimen collection tools for oral and upper respiratory specimens. Their portfolio also includes high-throughput microarray analysers and associated consumables, such as amplification mixes, reagent modules, and sample processing components designed for automated workflows.
The company’s products are regulated under FDA classifications, with some devices authorised as Class II and others as Class III. These devices are listed under the FDA’s 510(k), PMA, and UDI registries, reflecting their compliance with US regulatory requirements.
Catalogue
Search and filter all 28 devicesCompany details
- DUNS number
- 027914535
- Phone
- +1(760)477-2248
Frequently asked questions
How many devices does AUTOGENOMICS, INC have in the registry?
The registry currently lists 28 devices for AUTOGENOMICS, INC. Devices recorded under merged duplicate company entries are counted once.
Which registries list AUTOGENOMICS, INC's devices?
Among its 28 most recently registered devices, AUTOGENOMICS, INC has devices listed in FDA 510(k) (1 device), FDA PMA (1 device) and FDA GUDID (26 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do AUTOGENOMICS, INC's devices fall under?
Among its 28 most recently registered devices, the classes recorded for AUTOGENOMICS, INC's devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from AUTOGENOMICS, INC in the registry?
The most recently registered devices listed for AUTOGENOMICS, INC include INFINITI® Factor II-V Leiden BioFilmChip® Microarray Magazine 01-1050-01, INFINITI® High Throughput System (HTS) INCUBATOR 10-0070-99, INFINITI® High Throughput System (HTS) ACE ANALYZER 10-0030-99 and INFINITI® High Throughput System (HTS) PROCESSOR 10-0060-99.