Device Desk

Private service · Not FDA

FDA device establishment · Springfield, NJ

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-2245285As of September 30, 2026

DRG International, Inc.

Registration 2245285FEI 2245285Springfield, NJ

Owner/operator: BIOCHECK, INC.

  • Complaint File Establishment per 21 CFR 820.198
  • 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
142
Added, last 12 months
14

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 142

CodeDeviceClassRegulationPremarket
PCG21-Hydroxylase Autoantibody ELISA21-Hydroxylase Antibody (21-Ohab)Class 221 CFR 866.5660K121046
LRMANA Detect ELISAAnti-Dna Antibody (Enzyme-Labeled), Antigen, ControlClass 221 CFR 866.5100K030929
LRMAnti-dsDNA IgG ELISA, Anti-dsDNA IgM ELISA, Anti-dsDNA IgA ELISA, Anti-dsDNA Screen ELISAAnti-Dna Antibody (Enzyme-Labeled), Antigen, ControlClass 221 CFR 866.5100K953671
NHXEIA-5653 Anti-CCP.ELISAAntibodies, Anti-Cyclic Citrullinated Peptide (Ccp)Added May 18, 2026Class 221 CFR 866.5775—
MSTGliadin IgA ELISAAntibodies, GliadinClass 221 CFR 866.5750K990207
MSTGliadin IgG ELISAAntibodies, GliadinClass 221 CFR 866.5750K990204
KHWEntamoeba histolytica IgG ELISA, Entamoeba histolytica IgG ELISAAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.Class 221 CFR 866.3220—
GMOEIA-3865 Toxocara canis IgG ELISAAntigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.Class 221 CFR 866.3220—
GRYLeptospira IgG ELISA, Leptospira IgG ELISAAntigens, All, Leptospira Spp.Class 221 CFR 866.3350—
DBMEIA-3604 AMA-M2 ELISAAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, ControlAdded Aug 21, 2026Class 221 CFR 866.5090—
LJMAnti-Jo-1 ELISAAntinuclear Antibody (Enzyme-Labeled), Antigen, ControlsClass 221 CFR 866.5100K962053
LJMDNA (ds) IgG ELISAAntinuclear Antibody (Enzyme-Labeled), Antigen, ControlsClass 221 CFR 866.5100K933267

and 130 more on your full dossier

What changed

  • May 18, 2026Listing added: NHX — EIA-5653 Anti-CCP.ELISA
  • Aug 21, 2026Listing added: DBM — EIA-3604 AMA-M2 ELISA
  • Jun 15, 2026Listing added: LIP — EIA-3517 Treponema Pallidum (Syphillis) IgG
  • Jun 2, 2026Listing added: MXJ — HSV-1 IgM ELISA
  • May 11, 2026Listing added: LTJ — PSA Total
  • May 18, 2026Listing added: CGR — EIA-1887 Cortisol
  • Aug 21, 2026Listing added: MOB — EIA-3597 pANCA (MPO) ELISA
  • Sep 1, 2026Listing added: JHI — EIA-1911 Beta HCG ELISA
  • Jul 16, 2026Listing added: LJN — EIA-6204 EBV (EA) IgM ELISA
  • Sep 16, 2026Listing added: MCD — EIA-3476 EBV-VCA IgM ELISA
  • Apr 24, 2026Listing added: LSE — EBV-EBNA IgM ELISA
  • Sep 1, 2026Listing added: LYR — EIA-2111 Helicobacter pylori IgM ELISA
  • May 11, 2026Listing added: CDZ — SHBG ELISA
  • Jul 16, 2026Listing added: KTO — EIA- 3468 CMV IgG ELISA
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.

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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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