Device Desk

Private service · Not FDA

FDA device establishment · Sunnyvale, CA

This page shows the yearly renewal for this site, from FDA’s public record.

Device Desk is a private service. We are not FDA. We never file or pay for you.

Renewal dossierDD-3004530258As of September 30, 2026

CEPHEID

Registration 3004530258FEI 3004530258Sunnyvale, CA

Owner/operator: CEPHEID

  • Develop Specifications But Do Not Manufacture At This Facility
  • 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.

90days left in the window

The 2026 window

  1. Oct 1Window opens91 days left
  2. Nov 3Where you stand58 days left
  3. Dec 1Our pay-by date30 days left
  4. Dec 15Two weeks left16 days left
  5. Dec 23Holiday week8 days left
  6. Dec 29Two days left2 days left
  7. Dec 31Window closes0 days left
an email on that date our pay-by date to December 31
FDA fee, FY2027
$13,785
Our pay-by suggestion
Dec 1
Listed devices
103
Added, last 12 months
3

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

  1. 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 process

  2. Wait 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 process

  3. Renew 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 listing

  4. Review 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 103

CodeDeviceClassRegulationPremarket
OWDXpert Breast Cancer STRAT4Somatic Gene Mutation Detection SystemClass 3——
NAHXpert Bladder Cancer DetectionSystem, Test, Tumor Marker, For Detection Of Bladder CancerClass 3——
OAIXPERT EVAssay, Enterovirus Nucleic AcidClass 221 CFR 866.3225DEN070004
OYXXpert BCR-ABL UltraBcr/Abl1 Monitoring TestClass 221 CFR 866.6060K190076
OYXXpert BCR-ABL UltraBcr/Abl1 Monitoring TestClass 221 CFR 866.6060—
QDCXpert NPM1 MutationDna-Based Test For Minimal Residual Disease For Hematologic MalignanciesClass 221 CFR 866.6100—
LSLXpert CT/NGDna-Reagents, NeisseriaClass 221 CFR 866.3390K190441
LSLXpert CT/NGDna-Reagents, NeisseriaClass 221 CFR 866.3390—
PCHXpert GI PanelGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay SystemAdded Jan 28, 2026Class 221 CFR 866.3990K251721
PCHXpert NorovirusGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay SystemClass 221 CFR 866.3990K142501
PGXXpert Xpress Step AGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification SystemClass 221 CFR 866.2680—
PGXXpert Xpress Strep AGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification SystemClass 221 CFR 866.2680K172126

and 91 more on your full dossier

What changed

  • Jan 28, 2026Listing added: PCH — Xpert GI Panel (K251721)
  • Aug 18, 2026Listing added: QVR — Xpert® Hemorrhagic Fever (K261362)
  • Aug 18, 2026Listing added: OOI — Xpert® Hemorrhagic Fever (K261362)
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov). FDA does not endorse Device Desk.FDA’s own record is always the authority.

How we got this date

  1. FDA asks every device site to renew its registration each year.
  2. The renewal window runs from October 1, 2026 to December 31, 2026.
  3. A renewal in this window covers 2027.
  4. The rule is 21 CFR 807.22(b).

FDA’s record shows this registration runs through 2026.

We read this from FDA’s public record on September 30, 2026.

Read FDA’s page on registration

Watch for mail that looks like it is from FDA and asks you to pay a company. You pay FDA’s fee only in FDA’s own system.

Keep this desk: $249 a year

We keep this page current each week. We email you before each date in the window, and when FDA’s record shows you renewed.

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Renews each year until you cancel. Cancel any time from your account.

Is this right?

We copy this from FDA’s public record. FDA’s own record always wins. A listing missing here does not prove anything about FDA’s record.

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