AUTOGENOMICS, INCORPORATED
Registration 3005406097FEI 3005406097Carlsbad, CA
Owner/operator: Prescient Medicine Holdings Inc DBA SOLVD Health
- Manufacture Device in the United States for Export Only
- Manufacture Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 16
- Added, last 12 months
- 0
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 16
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| MAQ | Kit, Dna Detection, Human PapillomavirusUnknown | Class 3 | — | — |
| QZH | AvertD and AvertD Buccal Sample Collection KitOpioid Use Disorder Genetic Risk Variant Detection System And Collection Kit | Class 3 | — | P230032 |
| ODW | INFINITI Warfarin AssayCytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System | Class 2 | 21 CFR 862.3360 | K073014 |
| OYJ | INFINITI Buccal Sample Collection KitDna Specimen Collection, Saliva | Class 2 | 21 CFR 862.1675 | — |
| NTI | INFINITI CYP2C19 AssayDrug Metabolizing Enzyme Genotyping Systems | Class 2 | 21 CFR 862.3360 | K101683 |
| NTI | INFINITI CYP2C19+ AssayDrug Metabolizing Enzyme Genotyping Systems | Class 2 | 21 CFR 862.3360 | — |
| NSU | INFINITI FACTOR II AssayInstrumentation For Clinical Multiplex Test Systems | Class 2 | 21 CFR 862.2570 | K060564 |
| NSU | INFINITI CYP2C19 AssayInstrumentation For Clinical Multiplex Test Systems | Class 2 | 21 CFR 862.2570 | K101683 |
| NSU | INFINITI High Throughput SystemInstrumentation For Clinical Multiplex Test Systems | Class 2 | 21 CFR 862.2570 | — |
| NSU | INFINITI Warfarin AssayInstrumentation For Clinical Multiplex Test Systems | Class 2 | 21 CFR 862.2570 | K073014 |
| OMM | INFINITI MTHFR AssayTest 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr | Class 2 | 21 CFR 864.7280 | — |
| NPR | INFINITI FACTOR II AssayTest, Factor Ii G20210a Mutations, Genomic Dna Pcr | Class 2 | 21 CFR 864.7280 | K060564 |
and 4 more on your full dossier
What changed
Nothing added in the last twelve months, and no change seen on the record yet.