Diagnostic Automation/ Cortez Diagnostics Inc,.
Registration 2029372FEI 1000306617Woodland Hills, CA
Owner/operator: Diagnostic Automation /Cortez Diagnostics Inc.
- Manufacture Device in the United States for Export Only
- Manufacture Medical Device
- Remanufacture Medical Device
- Repack or Relabel 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
- 355
- Added, last 12 months
- 9
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 355
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| MTP | AccuDiag HLTV ElisaAntibody To Htlv-1, Elisa | Class 3 | — | — |
| LKV | Enzyme Immunoassay, Fetal FibronectinUnknown | Class 3 | — | — |
| LQI | HDV IgM ELISAHepatitis Delta Serological Reagents | Class 3 | — | — |
| KSJ | HBsAgSystem, Identification, Hepatitis B Antigen | Class 3 | — | — |
| MGX | Alcohol Urine testTest System, For Drugs Of Abuse | Class 3 | — | — |
| NCD | TBTest, Immunity, Cell Mediated, Mycobacterium Tuberculosis | Class 3 | — | — |
| MTF | PSA Rapid testTotal, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer | Class 3 | — | — |
| DFJ | InstaTestAlbumin, Rhodamine, Antigen, Antiserum, Control | Class 2 | 21 CFR 866.5040 | — |
| DRR | MyoglobinAmplifier And Signal Conditioner, Biopotential | Class 2 | 21 CFR 870.2050 | K022660 |
| LRM | ds-DNAAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control | Class 2 | 21 CFR 866.5100 | K923537 |
| GMS | FTA-ABSAnti-Human Globulin, Fta-Abs Test | Class 2 | 21 CFR 866.3830 | K781403 |
| MST | GliadinAntibodies, Gliadin | Class 2 | 21 CFR 866.5750 | K990207 |
and 343 more on your full dossier
What changed
- May 28, 2026Listing added: JIO — URS-1B (K023297)
- Aug 19, 2026Listing added: PSZ — Onestep Flu A & B Antigen RapiCard InstaTest (K250398)
- Jun 29, 2026Listing added: SEA — OneStep HBsAg /HCV /HIV /Syphilis Combo RapidCard InstaTest
- Feb 10, 2026Listing added: GQG — InstaTest RSV RapidCard
- Aug 17, 2026Listing added: LJY — AccuDiag Mumps IgM Elisa
- Jan 16, 2026Listing added: PCL — Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
- Aug 17, 2026Listing added: CGF — AccuDiag Estrone ELISA
- Jun 3, 2026Listing added: MDJ — AccuDiag Enhanced Toxocara IgG ELISA
- Dec 18, 2025Listing added: QKO — Onestep 2019-nCOV IgG/IgM Rapid Test Cassette InstaTest