Device Desk

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FDA device establishment · Canoga Park, CA

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Renewal dossierDD-3022178699As of September 30, 2026

IMMUNOCENTRIX CORPORATION

Registration 3022178699FEI 3022178699Canoga Park, CA

Owner/operator: ImmunoCentrix Corporation

  • Manufacture Device in the United States for Export Only

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
74
Added, last 12 months
74

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 74

CodeDeviceClassRegulationPremarket
LRMds-DNA ELISAAnti-Dna Antibody (Enzyme-Labeled), Antigen, ControlAdded Feb 18, 2026Class 221 CFR 866.5100—
GMSFTA-ABS IFAAnti-Human Globulin, Fta-Abs TestAdded Feb 19, 2026Class 221 CFR 866.3830—
PQOAMH ELISAAnti-Müllerian Hormone Test SystemAdded Feb 19, 2026Class 221 CFR 862.1092—
NHXAnti-CCP, Anti-CP ELISAAntibodies, Anti-Cyclic Citrullinated Peptide (Ccp)Added Feb 19, 2026Class 221 CFR 866.5775—
MSTGliadin IgG, IgA ELISAAntibodies, GliadinAdded Feb 19, 2026Class 221 CFR 866.5750—
KHWE. histolytica IgG, IgM , E. histolytica Dispar ELISAAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.Added Feb 19, 2026Class 221 CFR 866.3220—
LJMANA Screen ELISA, ANA-hep 2 IFAAntinuclear Antibody (Enzyme-Labeled), Antigen, ControlsAdded Feb 18, 2026Class 221 CFR 866.5100—
GRXLeptospira IgG, Leptospira IgM ELISAAntisera, All Leptospira Spp.Added Feb 19, 2026Class 221 CFR 866.3350—
GOOSalmonella IgG, IgM ELISAAntisera, Fluorescent, All Globulins, Salmonella Spp.Added Feb 19, 2026Class 221 CFR 866.3550—
GQLHSV 2 IgG, IgM ELISAAntisera, Fluorescent, Herpesvirus Hominis 1,2Added Feb 19, 2026Class 221 CFR 866.3305—
DBEASMA IFAAntismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, ControlAdded Feb 19, 2026Class 221 CFR 866.5120—
MVMAnti-Tissue Transglutaminase IgG, IgA ELISAAutoantibodies, Endomysial(Tissue Transglutaminase)Added Feb 18, 2026Class 221 CFR 866.5660—

and 62 more on your full dossier

What changed

  • Feb 18, 2026Listing added: LRM — ds-DNA ELISA
  • Feb 19, 2026Listing added: GMS — FTA-ABS IFA
  • Feb 19, 2026Listing added: PQO — AMH ELISA
  • Feb 19, 2026Listing added: NHX — Anti-CCP, Anti-CP ELISA
  • Feb 19, 2026Listing added: MST — Gliadin IgG, IgA ELISA
  • Feb 19, 2026Listing added: KHW — E. histolytica IgG, IgM , E. histolytica Dispar ELISA
  • Feb 18, 2026Listing added: LJM — ANA Screen ELISA, ANA-hep 2 IFA
  • Feb 19, 2026Listing added: GRX — Leptospira IgG, Leptospira IgM ELISA
  • Feb 19, 2026Listing added: GOO — Salmonella IgG, IgM ELISA
  • Feb 19, 2026Listing added: GQL — HSV 2 IgG, IgM ELISA
  • Feb 19, 2026Listing added: DBE — ASMA IFA
  • Feb 18, 2026Listing added: MVM — Anti-Tissue Transglutaminase IgG, IgA ELISA
  • Feb 18, 2026Listing added: DCK — C-Reactive Protein (CRP) ELISA
  • Feb 19, 2026Listing added: MHJ — Cryptosporidium ELISA
  • Feb 19, 2026Listing added: KLI — T3, T4 ELISA, Neo-Natal T3, Neo-Natal T4 ELISA
  • Feb 19, 2026Listing added: LFZ — CMV IgG, IgM ELISA
  • Feb 19, 2026Listing added: LGC — HSV 1 IgG, IgM ELISA
  • Feb 19, 2026Listing added: LFX — Rubella IgG, IgM ELISA
  • Feb 19, 2026Listing added: LGD — Toxoplasma IgG, IgM ELISA
  • Feb 19, 2026Listing added: LIP — Syphilis IgG, IgM ELISA
  • Feb 19, 2026Listing added: DBF — Ferritin ELISA
  • Feb 19, 2026Listing added: MHI — Giardia , Cryptosporidium/Giardia Ag ELISA
  • Feb 18, 2026Listing added: DGC — Total IgE ELISA
  • Feb 18, 2026Listing added: MMI — Troponin I ELISA
  • Feb 18, 2026Listing added: JNL — Anti-TPO ELISA
  • Feb 18, 2026Listing added: CDD — Vitamin B12 ELISA
  • Feb 18, 2026Listing added: CKG — ACTH ELISA
  • Feb 18, 2026Listing added: CJM — Aldosterone ELISA
  • Feb 18, 2026Listing added: CGR — Cortisol ELISA
  • Feb 19, 2026Listing added: CEC — Free T4 ELISA
  • Feb 18, 2026Listing added: CEW — Intact PTH ELISA
  • Feb 18, 2026Listing added: JLW — TSH ELISA
  • Feb 19, 2026Listing added: CDP — Free T3 ELISA
  • Feb 19, 2026Listing added: KHE — FOB Rapid Test
  • Feb 19, 2026Listing added: MID — Cardiolipin IgG, IgA, IgM , Total ELISA
  • Feb 18, 2026Listing added: JZG — Beta-2 Microglobulin ELISA
  • Feb 9, 2026Listing added: DHR — RF IgM ELISA
  • Feb 18, 2026Listing added: MRG — Vitamin D ELISA
  • Feb 19, 2026Listing added: MOB — MPO(p-ANCA), PR3 (c-ANCA)
  • Feb 18, 2026Listing added: NSF — AFP ELISA
  • Feb 19, 2026Listing added: DDC — Anti-Tg ELISA, Thyroglobulin ELISA
  • Feb 18, 2026Listing added: JHI — Beta hCG ELISA
  • Feb 19, 2026Listing added: GNH — Schistosoma IgG, Schistosoma IgM ELISA
  • Feb 19, 2026Listing added: GOW — Bordetella pertussis IgG, IgM
  • Feb 19, 2026Listing added: GPE — Echinococcus IgG, Echinococcus IgM ELISA
  • Feb 19, 2026Listing added: DDK — Beta-2-Glycoprotein 1 IgG, IgA, IgM ELISA
  • Feb 9, 2026Listing added: JNT — Anti-Phospholipid screen
  • Feb 19, 2026Listing added: JJQ — Microplate Washer, Microplate Reader, ELISA Analyzer
  • Feb 19, 2026Listing added: MDT — Trichinella IgG, Trichinella IgM ELISA
  • Feb 19, 2026Listing added: NDR — Inhibin A ELISA
  • Feb 19, 2026Listing added: LJC — Chlamydia IgG, IgM ELISA
  • Feb 18, 2026Listing added: LIQ — Rotavirus ELISA
  • Feb 19, 2026Listing added: MIU — Chagas ELISA, Chagas Rapid Test
  • Feb 18, 2026Listing added: LSE — EBV VCA IgG, EBV VCA IgM, EBV VCA IgA ELISA
  • Feb 9, 2026Listing added: LYR — H. pylori IgG, H. pylori IgM, H. pylori IgA ELISA, H. pylori Antigen ELISA
  • Feb 18, 2026Listing added: JLX — 17 OH Progesterone ELISA
  • Feb 18, 2026Listing added: CIZ — Androstenedione ELISA
  • Feb 18, 2026Listing added: JKD — C-Peptide ELISA
  • Feb 18, 2026Listing added: JKC — DHEA, DHEA-S ELISA
  • Feb 18, 2026Listing added: CHP — Estradiol ELISA
  • Feb 19, 2026Listing added: CGI — Estriol, Free Estriol (uE3) ELISA
  • Feb 18, 2026Listing added: CGF — Estrone ELISA
  • Feb 18, 2026Listing added: CGJ — FSH ELISA
  • Feb 18, 2026Listing added: CFL — HGH ELISA
  • Feb 18, 2026Listing added: CFP — Insulin ELISA
  • Feb 18, 2026Listing added: CEP — LH ELISA
  • Feb 19, 2026Listing added: JNG — Pregnenolone ELISA
  • Feb 18, 2026Listing added: JLS — Progesterone ELISA
  • Feb 18, 2026Listing added: CFT — Prolactin ELISA
  • Feb 18, 2026Listing added: CDZ — Testosterone ELISA, Free Testosterone ELISA, DHT ELISA
  • Feb 19, 2026Listing added: LOO — Leishmania IgG, Leishmania IgM ELISA
  • Feb 19, 2026Listing added: MDJ — T. solium (Cysticercosis IgG), T. solium (Cysticercosis IgM) ELISA
  • Feb 18, 2026Listing added: LLM — EBNA IgG , EBNA IgM ELISA
  • Feb 19, 2026Listing added: JLI — Folate 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.

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