Device Desk

Private service · Not FDA

FDA device establishment · Houston, TX

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-3009238284As of September 30, 2026

HEALGEN SCIENTIFIC LLC

Registration 3009238284FEI 3009238284Houston, TX

Owner/operator: HEALGEN SCIENTIFIC LLC

  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility
  • 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
189
Added, last 12 months
27

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 189

CodeDeviceClassRegulationPremarket
DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme MethodClinical ToxicologyClass 221 CFR 862.3040—
JIOHealgen Scientific LLC Healgen 500 Urine AnalyzerBlood, Occult, Colorimetric, In UrineClass 221 CFR 864.6550K111999
OSLControl, Fecal Occult BloodHematologyAdded Jun 9, 2026Class 221 CFR 864.6550—
DKZEnzyme Immunoassay, AmphetamineClinical ToxicologyClass 221 CFR 862.3100K150356
DKZEnzyme Immunoassay, AmphetamineClinical ToxicologyClass 221 CFR 862.3100K151642
DKZEnzyme Immunoassay, AmphetamineClinical ToxicologyClass 221 CFR 862.3100K163704
DKZEnzyme Immunoassay, AmphetamineClinical ToxicologyClass 221 CFR 862.3100K153597
DKZEnzyme Immunoassay, AmphetamineClinical ToxicologyClass 221 CFR 862.3100K143187
DKZEnzyme Immunoassay, AmphetamineClinical ToxicologyClass 221 CFR 862.3100K152269
DKZEnzyme Immunoassay, AmphetamineClinical ToxicologyAdded Apr 28, 2026Class 221 CFR 862.3100K253705
DISEnzyme Immunoassay, BarbiturateClinical ToxicologyClass 221 CFR 862.3150K153597
DISEnzyme Immunoassay, BarbiturateClinical ToxicologyClass 221 CFR 862.3150K163704

and 177 more on your full dossier

What changed

  • Jun 9, 2026Listing added: OSL — Control, Fecal Occult Blood
  • Apr 28, 2026Listing added: DKZ — Enzyme Immunoassay, Amphetamine (K253705)
  • Apr 28, 2026Listing added: LDJ — Enzyme Immunoassay, Cannabinoids (K253705)
  • Apr 28, 2026Listing added: DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites (K253705)
  • Apr 28, 2026Listing added: DJR — Enzyme Immunoassay, Methadone (K253705)
  • Apr 28, 2026Listing added: DJG — Enzyme Immunoassay, Opiates (K253705)
  • Apr 21, 2026Listing added: QYT — Heal-Check Rapid COVID-19 Antigen Self-Test (K260095)
  • Jan 12, 2026Listing added: NFT — Healgen Accurate Home Urine Drug Test Dip Card (K253567)
  • Jan 12, 2026Listing added: PTH — Healgen Accurate Home Urine Drug Test Dip Card (K253567)
  • Jan 12, 2026Listing added: NFV — Healgen Accurate Home Urine Drug Test Dip Card (K253567)
  • Jan 12, 2026Listing added: NFW — Healgen Accurate Home Urine Drug Test Dip Card (K253567)
  • Mar 2, 2026Listing added: NFW — Healgen® Accurate Oral Fluid Drug Test (K252523)
  • Jan 12, 2026Listing added: NFY — Healgen Accurate Home Urine Drug Test Dip Card (K253567)
  • Jan 12, 2026Listing added: PTG — Healgen Accurate Home Urine Drug Test Dip Card (K253567)
  • Jan 12, 2026Listing added: NGG — Healgen Accurate Home Urine Drug Test Dip Card (K253567)
  • Jan 12, 2026Listing added: NGL — Healgen Accurate Home Urine Drug Test Dip Card (K253567)
  • Jan 12, 2026Listing added: QBF — Healgen Accurate Home Urine Drug Test Dip Card (K253567)
  • Jan 12, 2026Listing added: QAW — Healgen Accurate Home Urine Drug Test Dip Card (K253567)
  • Apr 28, 2026Listing added: DJC — Thin Layer Chromatography, Methamphetamine (K253705)
  • Nov 27, 2025Listing added: NNI — HEAL-CHECK Pee Cup
  • Jan 12, 2026Listing added: JMT — Healgen® URS Test Strips (K251800)
  • Mar 2, 2026Listing added: MKU — Healgen® Accurate Oral Fluid Drug Test (K252523)
  • Jul 29, 2026Listing added: MKA — External Controls – Healgen Rapid Check COVID-19/Flu A&B Antigen Test Pro
  • Jul 29, 2026Listing added: MJZ — External Controls – Healgen Rapid Check COVID-19/Flu A&B Antigen Test Pro
  • Jan 12, 2026Listing added: LJX — Healgen® URS Test Strips (K251800)
  • Apr 28, 2026Listing added: LCM — Enzyme Immunoassay, Phencyclidine (K253705)
  • Jan 12, 2026Listing added: NGM — Healgen Accurate Home Urine Drug Test Dip Card (K253567)
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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