Device Desk

Private service · Not FDA

FDA device establishment · Wichita Falls, 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-3021841051As of September 30, 2026

BIALEX LAB

Registration 3021841051FEI 3021841051Wichita Falls, TX

Owner/operator: Bialex Lab

  • 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
55
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

  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 55

CodeDeviceClassRegulationPremarket
CKBBIALEX PHOSPHATASE ACIDAcid Phosphatase, Naphthyl PhosphateAdded Apr 18, 2026Class 221 CFR 862.1020—
CJRBIALEX ACID PHOSPHATASEAcid Phosphatase, Thymol Blue MonophosphateAdded Jul 7, 2026Class 221 CFR 862.1020—
CGXBIALEX CREATININEAlkaline Picrate, Colorimetry, CreatinineClass 221 CFR 862.1225K123586
JIIBIALEX LITHIUMAtomic Absorption, LithiumClass 221 CFR 862.3560K082001
CEKBIALEX PROTEIN U-CSFBiuret (Colorimetric), Total ProteinClass 221 CFR 862.1635—
CEKBIALEX TOTAL PROTEINBiuret (Colorimetric), Total ProteinClass 221 CFR 862.1635—
CJWBIALEX ALBUMIN BROMCRESOLBromcresol Purple Dye-Binding, AlbuminClass 221 CFR 862.1035K021636
JITBialex NaCalibrator, SecondaryClass 221 CFR 862.1150K042189
JFJBIALEX AMYLASECatalytic Methods, AmylaseClass 221 CFR 862.1070—
LRKBIALEX Lead Screen CheckDevice, Anti-SnoringClass 221 CFR 872.5570—
CIGBIALEX DYAZO TOTAL BILIRRUBINDiazo Colorimetry, BilirubinClass 221 CFR 862.1110K930679
CIGBIALEX DYAZO DIRECT BILIRRUBINDiazo Colorimetry, BilirubinClass 221 CFR 862.1110K931888

and 43 more on your full dossier

What changed

  • Apr 18, 2026Listing added: CKB — BIALEX PHOSPHATASE ACID
  • Jul 7, 2026Listing added: CJR — BIALEX ACID PHOSPHATASE
  • Jul 7, 2026Listing added: JGP — BIALEX TOTAL PROTEIN
  • Jul 7, 2026Listing added: JZG — BIALEX ANTI B2 MG
  • Apr 6, 2026Listing added: MRG — BIALEX VIT D
  • Apr 18, 2026Listing added: JMK — BIALEX HBDH Quant UV
  • Apr 18, 2026Listing added: JKL — BIALEX Lead Screen Check
  • Jul 7, 2026Listing added: JJG — BIOCHEMISTRY ANALYZER I-L600 & I-L400
  • Apr 18, 2026Listing added: JLZ — BIALEX BioPerformance 2,3-DPG
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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