Device Desk

Private service · Not FDA

FDA device establishment · Wilmington, DE

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-3042471840As of September 30, 2026

TOPTOLIFE DIAGNOSTICS LLC

Registration 3042471840FEI 3042471840Wilmington, DE

Owner/operator: Toptolife Diagnostics LLC

  • 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.

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
15
Added, last 12 months
15

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 15

CodeDeviceClassRegulationPremarket
JIOBlood, Occult, Colorimetric, In UrineHematologyAdded Jan 23, 2026Class 221 CFR 864.6550K111999
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)Clinical ChemistryAdded Jan 23, 2026Class 221 CFR 862.1340K111999
KHEReagent, Occult BloodHematologyAdded Dec 18, 2025Class 221 CFR 864.6550K162333
DHASystem, Test, Human Chorionic GonadotropinClinical ChemistryAdded Dec 18, 2025Class 221 CFR 862.1155K072500
JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)Clinical ChemistryAdded Jan 23, 2026Class 121 CFR 862.1095K111999
GTYAntigens, All Groups, Streptococcus Spp.MicrobiologyAdded Dec 18, 2025Class 121 CFR 866.3740K133343
KQOAutomated Urinalysis SystemClinical ChemistryAdded Jan 23, 2026Class 121 CFR 862.2900K111999
JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)Clinical ChemistryAdded Jan 23, 2026Class 121 CFR 862.1115K111999
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)Clinical ChemistryAdded Jan 23, 2026Class 121 CFR 862.1510K111999
CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)Clinical ChemistryAdded Jan 23, 2026Class 121 CFR 862.1785K111999
CENDye-Indicator, Ph (Urinary, Non-Quantitative)Clinical ChemistryAdded Jan 23, 2026Class 121 CFR 862.1550K111999
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)Clinical ChemistryAdded Jan 23, 2026Class 121 CFR 862.1645K111999

and 3 more on your full dossier

What changed

  • Jan 23, 2026Listing added: JIO — Blood, Occult, Colorimetric, In Urine (K111999)
  • Jan 23, 2026Listing added: JIL — Method, Enzymatic, Glucose (Urinary, Non-Quantitative) (K111999)
  • Dec 18, 2025Listing added: KHE — Reagent, Occult Blood (K162333)
  • Dec 18, 2025Listing added: DHA — System, Test, Human Chorionic Gonadotropin (K072500)
  • Jan 23, 2026Listing added: JMA — Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) (K111999)
  • Dec 18, 2025Listing added: GTY — Antigens, All Groups, Streptococcus Spp. (K133343)
  • Jan 23, 2026Listing added: KQO — Automated Urinalysis System (K111999)
  • Jan 23, 2026Listing added: JJB — Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) (K111999)
  • Jan 23, 2026Listing added: JMT — Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) (K111999)
  • Jan 23, 2026Listing added: CDM — Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) (K111999)
  • Jan 23, 2026Listing added: CEN — Dye-Indicator, Ph (Urinary, Non-Quantitative) (K111999)
  • Jan 23, 2026Listing added: JIR — Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) (K111999)
  • Jan 23, 2026Listing added: JIN — Nitroprusside, Ketones (Urinary, Non-Quant.) (K111999)
  • Jan 23, 2026Listing added: JRE — Refractometer For Clinical Use (K111999)
  • Jan 23, 2026Listing added: LJX — Test, Urine Leukocyte (K111999)
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

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

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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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