IMMUNOCENTRIX CORPORATION

FDA Device Registration & Listing · Canoga Park, CA, US · Registration 3022178699

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3022178699
FEI Number
3022178699
Entity Name
IMMUNOCENTRIX CORPORATION
City/State/Country
Canoga Park, CA, US
Establishment Address
7041 Owensmouth Ave Ste 103, Canoga Park, CA 91303, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
ImmunoCentrix Corporation (Owner Number: 10084773)
Owner / Operator Contact Address
7041 Owensmouth Ave., Suite 103, Canoga Park, CA 91303, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

RF IgM ELISA Chagas ELISA, Chagas Rapid Test Testosterone ELISA, Free Testosterone ELISA, DHT ELISA Progesterone ELISA C-Peptide ELISA Gliadin IgG, IgA ELISA Cryptosporidium ELISA Inhibin A ELISA EBNA IgG , EBNA IgM ELISA Toxoplasma IgG, IgM ELISA Anti-Tg ELISA, Thyroglobulin ELISA Intact PTH ELISA FSH ELISA 17 OH Progesterone ELISA Leptospira IgG, Leptospira IgM ELISA T. solium (Cysticercosis IgG), T. solium (Cysticercosis IgM) ELISA Estradiol ELISA Insulin ELISA HSV 1 IgG, IgM ELISA Vitamin D ELISA Ferritin ELISA Prolactin ELISA Estrone ELISA Trichinella IgG, Trichinella IgM ELISA Syphilis IgG, IgM ELISA Anti-Phospholipid screen FOB Rapid Test Anti-CCP, Anti-CP ELISA Rotavirus ELISA Androstenedione ELISA ds-DNA ELISA Bordetella pertussis IgG, IgM Microplate Washer, Microplate Reader, ELISA Analyzer AFP ELISA AMH ELISA DHEA, DHEA-S ELISA Anti-Tissue Transglutaminase IgG, IgA ELISA Beta hCG ELISA MPO(p-ANCA), PR3 (c-ANCA) Pregnenolone ELISA Cardiolipin IgG, IgA, IgM , Total ELISA Giardia , Cryptosporidium/Giardia Ag ELISA Vitamin B12 ELISA C-Reactive Protein (CRP) ELISA EBV VCA IgG, EBV VCA IgM, EBV VCA IgA ELISA Salmonella IgG, IgM ELISA Anti-TPO ELISA Echinococcus IgG, Echinococcus IgM ELISA Beta-2 Microglobulin ELISA

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DHR System, Test, Rheumatoid Factor Immunology Class 2 866.5775 2026-02-09
MIU Enzyme Linked Immunosorbent Assay, T. Cruzi Microbiology Class 1 866.3870 2026-02-19
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry Class 1 862.1680 2026-02-18
JLS Radioimmunoassay, Progesterone Clinical Chemistry Class 1 862.1620 2026-02-18
JKD Radioimmunoassay, C-Peptides Of Proinsulin Clinical Chemistry Class 1 862.1135 2026-02-18
MST Antibodies, Gliadin Immunology Class 2 866.5750 2026-02-19
MHJ Cryptosporidium Spp. Microbiology Class 2 866.3220 2026-02-19
NDR Enzyme Immunoassay, Inhibin-A Clinical Chemistry Class 1 862.1260 2026-02-19
LLM Test, Antigen, Nuclear, Epstein-Barr Virus Microbiology Class 1 866.3235 2026-02-18
LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Microbiology Class 2 866.3780 2026-02-19
DDC Thyroglobulin, Antigen, Antiserum, Control Immunology Class 2 866.5870 2026-02-19
CEW Radioimmunoassay, Parathyroid Hormone Clinical Chemistry Class 2 862.1545 2026-02-18
CGJ Radioimmunoassay, Follicle-Stimulating Hormone Clinical Chemistry Class 1 862.1300 2026-02-18
JLX Radioimmunoassay, 17-Hydroxyprogesterone Clinical Chemistry Class 1 862.1395 2026-02-18
GRX Antisera, All Leptospira Spp. Microbiology Class 2 866.3350 2026-02-19
MDJ Reagents, Cysticercosis Microbiology Class 1 866.3200 2026-02-19
CHP Radioimmunoassay, Estradiol Clinical Chemistry Class 1 862.1260 2026-02-18
CFP Radioimmunoassay, Immunoreactive Insulin Clinical Chemistry Class 1 862.1405 2026-02-18
LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific Microbiology Class 2 866.3305 2026-02-19
MRG System, Test, Vitamin D Clinical Chemistry Class 2 862.1825 2026-02-18
DBF Ferritin, Antigen, Antiserum, Control Immunology Class 2 866.5340 2026-02-19
CFT Radioimmunoassay, Prolactin (Lactogen) Clinical Chemistry Class 1 862.1625 2026-02-18
CGF Radioimmunoassay, Estrone Clinical Chemistry Class 1 862.1280 2026-02-18
MDT Elisa, Trichinella Spiralis Microbiology Class 1 866.3850 2026-02-19
LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum Microbiology Class 2 866.3830 2026-02-19
JNT Chromatographic, Phospholipids Clinical Chemistry Class 1 862.1575 2026-02-09
KHE Reagent, Occult Blood Hematology Class 2 864.6550 2026-02-19
NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) Immunology Class 2 866.5775 2026-02-19
LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus Microbiology Class 1 866.3405 2026-02-18
CIZ Radioimmunoassay, Androstenedione Clinical Chemistry Class 1 862.1075 2026-02-18
LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control Immunology Class 2 866.5100 2026-02-18
GOW Antisera, Agglutinating, B. Parapertussis Microbiology Class 1 866.3065 2026-02-19
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use Clinical Chemistry Class 1 862.2300 2026-02-19
NSF Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment Immunology Class 2 866.6030 2026-02-18
PQO Anti-Müllerian Hormone Test System Clinical Chemistry Class 2 862.1092 2026-02-19
JKC Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) Clinical Chemistry Class 1 862.1245 2026-02-18
MVM Autoantibodies, Endomysial(Tissue Transglutaminase) Immunology Class 2 866.5660 2026-02-18
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2026-02-18
MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) Immunology Class 2 866.5660 2026-02-19
JNG Radioimmunoassay, Pregnenolone Clinical Chemistry Class 1 862.1615 2026-02-19
MID System, Test, Anticardiolipin Immunological Immunology Class 2 866.5660 2026-02-19
MHI Giardia Spp. Microbiology Class 2 866.3220 2026-02-19
CDD Radioassay, Vitamin B12 Clinical Chemistry Class 2 862.1810 2026-02-18
DCK C-Reactive Protein, Antigen, Antiserum, And Control Immunology Class 2 866.5270 2026-02-18
LSE Epstein-Barr Virus, Other Microbiology Class 1 866.3235 2026-02-18
GOO Antisera, Fluorescent, All Globulins, Salmonella Spp. Microbiology Class 2 866.3550 2026-02-19
JNL Immunochemical, Thyroglobulin Autoantibody Immunology Class 2 866.5870 2026-02-18
GPE Antisera, Positive Control, Echinococcus Spp. Microbiology Class 1 866.3200 2026-02-19
JZG System, Test, Beta-2-Microglobulin Immunological Immunology Class 2 866.5630 2026-02-18

Official Correspondent

Mina Kateb

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ImmunoCentrix Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K954575 Abbott Laboratories AXSYM TOXO IGG ANTIBODY ASSAY 1996-08-16
K032162 Beckman Coulter, Inc. ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY 2003-08-08
K811566 Immuno Nuclear Corp. C-TERMINAL PTH BY RADIOIMMUNOASSAY KIT 1981-06-25
K133601 Siemens Healthcare Diagnostics, Inc. ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY 2014-02-05
K833852 Syncor Intl. Corp. FSH RIA 1984-01-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-2013 Beckman Coulter Inc. 2
IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.
Z-0128-2015 Siemens Healthcare Diagnostics, Inc 2
ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack)
Z-0129-2015 Siemens Healthcare Diagnostics, Inc 2
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 06567787 (6 pack)
Z-0130-2015 Siemens Healthcare Diagnostics, Inc 2
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 672182005 (US Reference 6 pack)
Z-0003-2007 N/A 2
Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022178699. Last updated year: 2026. Please use registration number 3022178699 when referencing this establishment in official correspondence.
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