Device Desk

Private service · Not FDA

FDA device establishment · West Hills, 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-2024375As of September 30, 2026

ONE LAMBDA, INC.

Registration 2024375FEI 2024375West Hills, CA

Owner/operator: One Lambda, Inc.

  • Complaint File Establishment per 21 CFR 820.198
  • 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
34
Added, last 12 months
1

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 34

CodeDeviceClassRegulationPremarket
QUKSeCore™ CDx HLA Sequencing SystemHuman Leukocyte Antigen (Hla) Typing Companion Diagnostic TestAdded Aug 19, 2026Class 221 CFR 866.5960BK261357
QUKSeCore™ CDx HLA Sequencing SystemHuman Leukocyte Antigen (Hla) Typing Companion Diagnostic TestClass 221 CFR 866.5960BK241074
QUKSeCore™ CDx HLA Sequencing SystemHuman Leukocyte Antigen (Hla) Typing Companion Diagnostic TestClass 221 CFR 866.5960—
JJNMicro SSP Gel SystemApparatus, Electrophoresis, For Clinical UseClass 121 CFR 862.2485—
PEROne Lambda HLA PROAutomated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric AnalysisClass 121 CFR 862.2750—
JCFFluorobeadsLymphocyte Separation MediumClass 121 CFR 864.8500—
KQCFluoroquench Staining/Quench ReagentStains, HematologyClass 121 CFR 864.1850—
JQWLABXpress Reflex Commander PippeterStation, Pipetting And Diluting, For Clinical UseClass 121 CFR 862.2750—
LGOTerasaki Tissue Typing Trays and Lambda Monoclonal TraysTest, Leukocyte TypingClass 121 CFR 864.7675—
MZILABScreen™ MultiTest, Qualitative, For Hla, Non-DiagnosticUnclassified—BK200546
MZIFlowPRATest, Qualitative, For Hla, Non-DiagnosticUnclassified—BK980015
MZIAllSet Gold SSPTest, Qualitative, For Hla, Non-DiagnosticUnclassified—BK070038

and 22 more on your full dossier

What changed

  • Aug 19, 2026Listing added: QUK — SeCore™ CDx HLA Sequencing System (BK261357)
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

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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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