BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Diagnostic Automation/ Cortez Diagnostics Inc,.

    Reg #: 2029372 · FEI: 1000306617 · Expires 2026
    View on FDA
    Products
    191
    Proprietary Names
    224
    Establishment Types
    4
    Classifications
    190

    Registration Details

    Registration Name
    Diagnostic Automation/ Cortez Diagnostics Inc,.
    Registration Number
    2029372
    FEI Number
    1000306617
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    21250 Califa St Suite 102 and 116
    City
    Woodland Hills
    State
    CA
    ZIP
    91367
    Country
    US

    Regulatory Submissions

    510(k) Number
    K022501

    Owner / Operator

    Firm Name
    Diagnostic Automation /Cortez Diagnostics Inc.
    Operator Number
    9011974
    Address
    21250 Califa St,, SUITE 102 and 116
    City
    Woodland Hills
    State
    CA
    Postal Code
    91367
    Country
    US
    Correspondent
    PAUL - SHAW

    Products

    Device Name Product Code
    Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test QST
    Antisera, Positive Control, Echinococcus Spp. GPE
    System, Test, Systemic Lupus Erythematosus DHC
    Thin Layer Chromatography, Methamphetamine DJC
    System, Test, Infectious Mononucleosis KTN
    Radioimmunoassay, C-Peptides Of Proinsulin JKD
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Antisera, Latex Agglutination, Cryptococcus Neoformans GMD
    Antigen, Ebv, Capsid MCD
    Helicobacter Pylori LYR
    Enzyme Linked Immunosorbent Assay, T. Cruzi MIU
    Reagent, Borrelia Serological Reagent LSR
    Reagents, Cysticercosis MDJ
    Antisera, Cf, Herpesvirus Hominis 1,2 GQO
    Enzyme Immunoassay, Opiates DJG
    System, Identification, Hepatitis B Antigen KSJ
    Immunochemical, Thyroglobulin Autoantibody JNL
    Giardia Spp. MHI
    Radioimmunoassay, Digoxin (125-I) LCS
    Radioimmunoassay, Testosterones And Dihydrotestosterone CDZ
    Beta-2-Glycoprotein I, Antigen, Antiserum, Control DDN
    Antigen, Elisa, Cryptococcus MDU
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Benzodiazepine JXM
    Enzyme Immunoassay, Phencyclidine LCM
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
    Enzyme Immunoassay, Methadone DJR
    Enzyme Immunoassay, Amphetamine DKZ
    Enzyme Immunoassay, Barbiturate DIS
    Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster LFY
    Visual, Pregnancy Hcg, Prescription Use JHI
    Radioimmunoassay, Human Growth Hormone CFL
    Antisera, Control For Nontreponemal Tests GMP
    Elisa, Antibody, West Nile Virus NOP
    Direct Agglutination Test, Toxoplasma Gondii LLA
    Thyroglobulin, Antigen, Antiserum, Control DDC
    Amplifier And Signal Conditioner, Biopotential DRR
    Antiserum, Fluorescent, Epstein-Barr Virus JRY
    System, Test, Thyroid Autoantibody JZO
    System, Test, C-Reactive Protein DCN
    Glucose Oxidase, Glucose CGA
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Test, Urine Leukocyte LJX
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Refractometer For Clinical Use JRE
    Blood, Occult, Colorimetric, In Urine JIO
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Electrolyte Controls (Assayed And Unassayed) JJR
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii LGD
    Enzyme Linked Immunoabsorption Assay, Treponema Pallidum LIP
    Test, Vaginal, Bacterial Sialidase MXB
    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) LOM
    Test, Hiv Detection MZF
    Hemoglobin, Chain Specific, Antigen, Antiserum, Control DAM
    Antigen, Agglutinating, Echinococcus Spp. GPF
    Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls LJM
    Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) LJC
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Radioimmunoassay, Thyroxine-Binding Globulin CEE
    Antigen, Fluorescent Antibody Test, Schistosoma Mansoni GNH
    Enzyme Linked Immunoabsorbent Assay, Rubella LFX
    System, Test, Rheumatoid Factor DHR
    Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens PMT
    Automated Urinalysis System KQO
    Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment NSF
    Device, Microtiter Diluting/Dispensing JTC
    Radioimmunoassay, Immunoreactive Insulin CFP
    C-Reactive Protein, Antigen, Antiserum, And Control DCK
    Test System, For Drugs Of Abuse MGX
    Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt PVA
    Colorimeter, Photometer, Spectrophotometer For Clinical Use JJQ
    Radioimmunoassay, Androstenedione CIZ
    Antisera, Cf, Influenza Virus A, B, C GNW
    Radioimmunoassay, 17-Hydroxyprogesterone JLX
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Test System, Antineutrophil Cytoplasmic Antibodies (Anca) MOB
    Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. GNC
    System, Test, Anticardiolipin Immunological MID
    Reagent, Coronavirus Serological QKO
    Test, Screening, For D Positive Fetal Rbc'S LIM
    Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control DBE
    Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus LFZ
    Kit, Identification, Neisseria Gonorrhoeae JSX
    Gas Chromatography, Methamphetamine LAF
    Container, Specimen, Urine, Drugs Of Abuse, Over The Counter MPQ
    Test, Cannabinoid, Over The Counter NFW
    Antigens, Nontreponemal, All GMQ
    Hepatitis A Test (Antibody And Igm Antibody) LOL
    Antibody Igm,If, Cytomegalovirus Virus LKQ
    Radioimmunoassay, Total Triiodothyronine CDP
    Epstein-Barr Virus, Other LSE
    Chamber, Slide Culture KIY
    Radioimmunoassay, Free Thyroxine CEC
    Chromatographic Separation, Cpk Isoenzymes JHT
    System, Test, Carcinoembryonic Antigen DHX
    Cryptosporidium Spp. MHJ
    Calibrator, Secondary JIT
    Kit, Test, Multiple, Drugs Of Abuse, Over The Counter MVO
    Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 MYF
    Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 MXJ
    Reagents, Test, Tetrahydrocannabinol DKE
    System, Test, Vitamin D MRG
    Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus GQG
    Test, Antigen, Nuclear, Epstein-Barr Virus LLM
    Trichomonas Vaginalis Nucleic Acid Amplification Test System OUY
    Antibodies, Gliadin MST
    Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific LGC
    Radioimmunoassay, Progesterone JLS
    Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine KLI
    Enzyme Linked Immunoabsorbent Assay, Rubeola Igm PCL
    Enzyme Linked Immunoabsorbent Assay, Mumps Virus LJY
    C. Trachomatis (Chlamydia Group) MGM
    Antigens, If, Toxoplasma Gondii GLZ
    Reagents, Antibody, Legionella, Direct & Indirect Fluorescent LHL
    Lipoprotein X, Antigen, Antiserum, Control DEL
    Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control DHN
    Test, Syphilis, Treponemal MTN
    Extractable Antinuclear Antibody, Antigen And Control LLL
    Covid-19 Multi-Analyte Antigen Device QMN
    Antigens, All, Leptospira Spp. GRY
    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer MTF
    Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control DBL
    Antisera, All Leptospira Spp. GRX
    Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control DBM
    Antisera, Fluorescent, Herpesvirus Hominis 1,2 GQL
    Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. LJZ
    Immunoassay Method, Troponin Subunit MMI
    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis NCD
    Elisa, Trichinella Spiralis MDT
    Antistreptolysin - Titer/Streptolysin O Reagent GTQ
    Device, General Purpose, Microbiology, Diagnostic LIB
    Devices Detecting Influenza A, B, And C Virus Antigens PSZ
    Legionella, Spp., Elisa MJH
    Station, Pipetting And Diluting, For Clinical Use JQW
    Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) JKC
    Reagents For Detection Of Norovirus Nucleic Acid PIQ
    Lipoprotein, Low-Density, Antigen, Antiserum, Control DFC
    Enzyme Linked Immunoabsorbent Assay, Rotavirus LIQ
    Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use KSX
    Enzyme Immunoassay, Fetal Fibronectin LKV
    Radioimmunoassay, Luteinizing Hormone CEP
    Norovirus Serological Reagent OUC
    Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control LRM
    Antigen, Cf (Including Cf Control), Cytomegalovirus GQH
    Kit, Screening, Staphylococcus Aureus JWX
    Forensic Evidence Sexual Assault Kit OHE
    Radioimmunoassay, Estriol CGI
    Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device PJD
    Antigen, Cf, (Including Cf Control), Varicella-Zoster GQW
    Antigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus GPD
    Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control DAP
    Dengue Virus Antigen Assay QCU
    Reagent, Occult Blood KHE
    Radioassay, Triiodothyronine Uptake KHQ
    Antibody To Htlv-1, Elisa MTP
    Antibody Igm, If, Epstein-Barr Virus LJN
    Antisera, All Groups, Streptococcus Spp. GTZ
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Thin Layer Chromatography, Tricyclic Antidepressant Drugs MLK
    Hepatitis Delta Serological Reagents LQI
    Test System, Nicotine, Cotinine, Metabolites MRS
    Immunoassay, Insulin-Like Growth Factor Binding Protein-1 OAM
    Calprotectin, Fecal NXO
    NCI
    Test, Benzodiazepine, Over The Counter NFV
    Ferritin, Antigen, Antiserum, Control DBF
    Dengue Serological Reagents OSU
    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus MZO
    Latex Agglutination Assay, Rubella LQN
    Radioimmunoassay, Prolactin (Lactogen) CFT
    Albumin, Rhodamine, Antigen, Antiserum, Control DFJ
    Radioimmunoassay, Estradiol CHP
    Kit, Screening, Trichomonas JWZ
    Anti-Human Globulin, Fta-Abs Test GMS
    Test, Sickle Cell GHM
    Coronavirus Antigen Detection Test System. QKP
    Radioimmunoassay, Follicle-Stimulating Hormone CGJ
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Test, Methamphetamine, Over The Counter NGG
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Methadone, Over The Counter PTG
    Test, Morphine, Over The Counter NGI
    Test, Phencyclidine (Pcp), Over The Counter NGM
    Thin Layer Chromatography, Morphine DNK
    Test, Barbiturate, Over The Counter PTH
    Test, Opiates, Over The Counter NGL
    Test, Amphetamine, Over The Counter NFT

    Proprietary Names

    AccuDiag HIV NAT Elisa Echinococcus IgG ELISA InstaTestTM Methamphetamine Mono rapid NeoNatal TSH ELISA Filariasis IgG/IgM Rapid test EBV VCA IgG H. pylori IgG Chagas Rapid test Lyme T. solium (Cysticercosis) Herpes Simplex Virus Serological assay Opiate HBsAg Chagas AccuDiag™ Thyroid peroxidase (TPO) Giardia ELISA Digoxin Testosterone ELISA Mult-Drug combination Urine RapiCard™/ Multi-Drug combination Urine RapiDip™/ Multi-Drug combination Urine RapiCup™ Multi Drug Panel cup OneStep Mult-Drug combination Urine RapiCard™/ Multi-Drug combination Urine RapiDip™/ M-Drug combination Urine RapiCup™ AccuDiag™ Varicella Zoster IgG (VZV IgG) ELISA QMedix™ Varicella Zoster IgG (VZV IgG) ELISA InstaTest HCG West Nile IgM Onestep Toxoplasma RapiCardTM InstaTest Thyroglobulin Myoglobin EBV Thyroid autoantibody CRP Latex InstaTest Urine InstaTest™ -Urine reagent strip Toxoplasma ELISA Qmedix OneStep hCG Combo (Urine/Serum/Plasma) RapiCardTM InstaTest Ascaris H. pylori Antigen H.pylori ENA profile AccuDiag Chlamydia Onestep Methadone InstaTest Urine strip reagents QMedix™ Thyroid Binding Globulin (TBG) ELISA AccuDiag™ Thyroid Binding Globulin (TBG) ELISA Schistosoma IgG Rubella RF Urine Analyzer AFP Rapid Test Microplate washer CRP Latex Alcohol Urine test Onestep Cocaine RapiCardTM InstaTest Microplate reader SF2100 Influenza A&B rapid hCG pregnancy rapid test OneStep InstaTest HCG Combo Urine/Serum RapiCard ANCA Screen PCP Salmonella typhi rapid test Cardiolipin IgA Onestep 2019-nCOV IgG/IgM Rapid Test Cassette InstaTest BZD card ASA Borrelia BZD strip QMedix™ Cytomegalovirus IgM (CMV IgM) ELISA AccuDiag™ Cytomegalovirus IgM (CMV IgM) ELISA Gonorrhea Rapid test Multi-Drug Panel RapiCup™ OneStep Multi-Drug Panel RapiCup™ Onestep Marijuana (THC) RapiCardTM InstaTest Synthetic Marijuana RPR Latex CMV ELISA CMV AccuDiag™ Free T3 ELISA QMedix™ Free T3 ELISA Onestep Cannabinoids InstaTest IFA slides Free T4 OneStep HCG Combo RapiDip™ InstaTest (Urine/Serum) HCG Combo RapiDip™ InstaTest (Urine/Serum) TPO IgG OneStep CK-MB RapiCard™ InstaTest CEA Rapid test EBV VCA IgM Toxocara IgG RF Latex D-Dimer Rapid test Multi-Drug test panel Onestep Multi-Drug InstaTest HSV 1&2 Onestep Tetrahydrocannabinol InstaTest VZV IgM Vitamin D Rapid test RSV RapidTest Cassette InstaTest RSV RapidCard EBNA IgG Onestep Vaginalis InstaTest HAV IgM rapid AccuDiag™ Free Testosterone ELISA Crypto/Giardia Gliadin Chemistry Analyzer SF4500 HSV Cardiolipin IgG AccuDiag™ T4 ELISA Cryptosporidium Mumps IgG Chlamydia male/female rapid test T4 Cardiolipin IgM Toxoplasma IFA QMedix™ Rubella IgM ELISA AccuDiag™ Rubella IgM ELISA Legionella Ultra Sensitive TSH ANA Chlamydia trachomatis IgG Syphilis Rapid test AccuDiag™ ANA Screen Elisa Influenza A & B plus COVID-19 Antigen Combo RapiCard™ InstaTest TSH Leptospira IgM ELISA PSA Rapid test Leptospira IgG/IgM RapidTest™ Cassette AMA Herpes Syphilis IgG Mycoplasma IgG Troponin I Onestep Cocaine Metabolites InstaTest HCG Urine Midstream InstaTest OneStep HCG Urine Midstream InstaTest TB AccuDiag™ Strongyloides IgG ELISA OneStep Filariasis IgG/IgM RapidTest T3 OneStep Multi-Drug Panel (RapiCard™ and RapiDip™) (Laboratory/POC) Multi-Drug Panel (RapiCard™ and RapiDip™) (Laboratory/POC) PR3 Microplate washer 2600 AccuDiag™ Enhanced Toxocara IgG ELISA Rubella ELISA AccuDiag™ DHEA ELISA InstaTest Norovirus Lp (a) Rotavirus ELISA OneStep LH Urine RapiCard™ InstaTest LH Urine RapiCard™ InstaTest Norovirus Rapid test ds-DNA AccuDiag™ Thyrglobulin ELISA Color Staph Latex Scl-70 Sexual combo Transmitted Syphilis, Hepatitis, HIV AccuDiag™ Leptospira IgG ELISA Trichinella IgG SS-A (Ro) Alcohol Saliva rapid test Onestep Alcohol Saliva RapiCardTM InstaTest VZV EBNA IgM AccuDiag™ ECHINOCOCCUS OneStep D-dimer RapiCard™ InstaTest AccuDiag™ Dengue NS1 ELISA QMedix™ Dengue NS1 ELISA OneStep FOB RapiCard™ InstaTest FOB RapiCard™ InstaTest C-reactive protein T3 Uptake AccuDiag™ HLTV Elisa Strep A InstaTest™ VZV IgG Onestep LH RapiCardTM InstaTest Mult-Drug combination Urine Panel (RapiCard™/ RapiDip™/ RapiCup™)- Home Use Mult-Drug combination Urine Panel (RapiCard™/ RapiDip™) & Multi-Drug RapiCup™- Home Use OneStep Mult-Drug combination Urine Panel (RapiCard™/ RapiDip™) & Multi-Drug RapiCup™- Home Use TCA HSV 1 IgG Fecal Occult Blood InstaTest™ HDV IgM ELISA InstaTestCotinine URS-1B FOB rapid test Onestep MDMA RapiCardTM InstaTest AccuDiag™ LH Elisa QMedix™ LH ELISA AccuDiag™ Rubella IgG ELISA QMedix™ Rubella IgG ELISA Sm/RNP ELISA Single-Drug Urine RapiCard™/Single-Drug RapiDip™/Single-Drug RapiCup™ (Laboratory/POC) OneStep Single-Drug Urine RapiCard™/Single-Drug RapiDip™/Single-Drug RapiCup™ (Laboratory/POC) ASO Latex QMedix™ Toxoplasma IgM ELISA AccuDiag™ Toxoplasma IgM ELISA Ferritin Measles IgM OneStep Fentanyl RapidCard InstaTest (Urine) Dengue IgM ELISA Rubella InstaTest AccuDiag™ Prolactin Elisa Glucose urine strip AccuDiag™ Cytomegalovirus IgG (CMV IgG) ELISA QMedix™ Cytomegalovirus IgG (CMV IgG) ELISA Mycoplasma IgM FOB InstaTest™ FTA-ABS HCG Urine RapiCard™ InstaTest OneStep HCG Urine RapiCard™ InstaTest AccuDiag FSH ELISA QMedix FSH ELISA AccuDiag HBsAg Mult-Drug Combination Urine RapiCup™ -OTC Use/ Prescription Use OneStep Mult-Drug Combination Urine RapiCup™ -OTC Use/ Prescription Use MPO QMedix™ Toxoplasma IgG ELISA AccuDiag™ Toxoplasma IgG ELISA OneStep HCG Urine RapiDip™ InstaTest HCG Urine RapiDip™ InstaTest Onestep HCG RapiCardTM InstaTest

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device Repack or Relabel Medical Device Remanufacture Medical Device