Device Desk

Private service · Not FDA

FDA device establishment · Birmingham, AL

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-3010749841As of September 30, 2026

BIOGX

Registration 3010749841FEI 3010749841Birmingham, AL

Owner/operator: BioGX

  • 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
15
Added, last 12 months
13

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
OZZBioGX - Bordetella Speciation Plus Toxin - OSR for BD MAXBordetella Pertussis Dna Assay SystemClass 221 CFR 866.3980—
PIIBioGX - Candida Speciation GATPK - OSR for BD MAXCandida Species Nucleic Acid Detection SystemAdded Mar 18, 2026Class 221 CFR 866.3960—
PEOBioGX - Pneumocystis jirovecii - OSR for BD MAXFungal Organisms, Nucleic Acid-Based AssayAdded Mar 18, 2026Class 221 CFR 866.3365—
PCHBioGX - Parasitic Enteric CGED - OSR for BD MAXGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay SystemAdded Mar 18, 2026Class 221 CFR 866.3990—
PENBioGX - Carbapenem Resistance KNO - OSR for BD MAXGram-Negative Bacteria And Associated Resistance MarkersAdded Mar 18, 2026Class 221 CFR 866.3365—
PAMBioGX - Vancomycin Resistance - OSR for BD MAXGram-Positive Bacteria And Their Resistance MarkersAdded Mar 18, 2026Class 221 CFR 866.3365—
PGIBioGX - Lesion HSVHD - OSR for BD MAXHerpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion SamplesAdded Mar 18, 2026Class 221 CFR 866.3309—
QBHBioGX - Mycobacterium tuberculosis Complex - OSR for BD MAXLower Respiratory Microbial Nucleic Acid Detection SystemAdded Mar 18, 2026Class 221 CFR 866.3985—
PLOBioGX - Bacterial Meningitis ELGBS - OSR for BD MAXMeningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection SystemAdded Mar 18, 2026Class 221 CFR 866.3970—
OZXBioGX - Mycoplasma-Ureaplasma - OSR for BD MAXMycoplasma Pneumoniae Dna Assay SystemAdded Mar 18, 2026Class 221 CFR 866.3980—
QEPBioGX - Syphilis - OSR for BD MAXNucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted InfectionsAdded Mar 18, 2026Class 221 CFR 866.3393—
OCCBioGX - Flu A, Flu B, RSV A/B - OSR for BD MAXRespiratory Virus Panel Nucleic Acid Assay SystemAdded Mar 18, 2026Class 221 CFR 866.3980—

and 3 more on your full dossier

What changed

  • Mar 18, 2026Listing added: PII — BioGX - Candida Speciation GATPK - OSR for BD MAX
  • Mar 18, 2026Listing added: PEO — BioGX - Pneumocystis jirovecii - OSR for BD MAX
  • Mar 18, 2026Listing added: PCH — BioGX - Parasitic Enteric CGED - OSR for BD MAX
  • Mar 18, 2026Listing added: PEN — BioGX - Carbapenem Resistance KNO - OSR for BD MAX
  • Mar 18, 2026Listing added: PAM — BioGX - Vancomycin Resistance - OSR for BD MAX
  • Mar 18, 2026Listing added: PGI — BioGX - Lesion HSVHD - OSR for BD MAX
  • Mar 18, 2026Listing added: QBH — BioGX - Mycobacterium tuberculosis Complex - OSR for BD MAX
  • Mar 18, 2026Listing added: PLO — BioGX - Bacterial Meningitis ELGBS - OSR for BD MAX
  • Mar 18, 2026Listing added: OZX — BioGX - Mycoplasma-Ureaplasma - OSR for BD MAX
  • Mar 18, 2026Listing added: QEP — BioGX - Syphilis - OSR for BD MAX
  • Mar 18, 2026Listing added: OCC — BioGX - Flu A, Flu B, RSV A/B - OSR for BD MAX
  • Mar 18, 2026Listing added: OLX — BioGX - EBV - OSR for BD MAX
  • Mar 18, 2026Listing added: OYZ — BioGX - Group A Streptococcus - OSR for BD MAX
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.

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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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