Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2029372

FEI Number

1000306617

Entity Name

Diagnostic Automation/ Cortez Diagnostics Inc,.

City/State/Country

Woodland Hills, CA, US

Establishment Address

21250 Califa St Suite 102 and 116, Woodland Hills, CA 91367, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Diagnostic Automation /Cortez Diagnostics Inc. (Owner Number: 9011974)

Owner / Operator Contact Address

21250 Califa St,, SUITE 102 and 116, Woodland Hills, CA 91367, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K152122

PMA Number

N/A

All Registered 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 Rubella 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 Toxoplasma ELISA CMV ELISA CMV AccuDiag Free T3 ELISA QMedix Free T3 ELISA EBV 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 CMV 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 Toxoplasma IFA Legionella Ultra Sensitive TSH ANA Chlamydia trachomatis IgG Syphilis Rapid test AccuDiag ANA Screen Elisa EBV Influenza A & B plus COVID-19 Antigen Combo RapiCard InstaTest TSH Leptospira IgM ELISA PSA Rapid test Lyme ASA 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 Legionella 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 AMA 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 CMV 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 ANA AccuDiag Dengue NS1 ELISA QMedix Dengue NS1 ELISA OneStep FOB RapiCard InstaTest FOB RapiCard InstaTest C-reactive protein T3 Uptake AccuDiag HLTV Elisa EBV 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QST	Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test	Microbiology	Class 2	866.3957	2024-05-06
GPE	Antisera, Positive Control, Echinococcus Spp.	Microbiology	Class 1	866.3200	2017-12-17
DHC	System, Test, Systemic Lupus Erythematosus	Immunology	Class 2	866.5820	2023-10-04
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2008-04-22
KTN	System, Test, Infectious Mononucleosis	Immunology	Class 2	866.5640	2018-05-07
JKD	Radioimmunoassay, C-Peptides Of Proinsulin	Clinical Chemistry	Class 1	862.1135	2016-05-20
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2017-12-15
GMD	Antisera, Latex Agglutination, Cryptococcus Neoformans	Microbiology	Class 2	866.3165	2018-08-20
MCD	Antigen, Ebv, Capsid	Microbiology	Class 1	866.3235	2017-12-15
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2008-04-23
MIU	Enzyme Linked Immunosorbent Assay, T. Cruzi	Microbiology	Class 1	866.3870	2017-12-17
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2008-04-18
MDJ	Reagents, Cysticercosis	Microbiology	Class 1	866.3200	2017-12-15
GQO	Antisera, Cf, Herpesvirus Hominis 1,2	Microbiology	Class 2	866.3305	2021-10-24
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2008-11-18
KSJ	System, Identification, Hepatitis B Antigen	Unknown	Class 3	N/A	2017-04-10
MIU	Enzyme Linked Immunosorbent Assay, T. Cruzi	Microbiology	Class 1	866.3870	2017-12-11
JNL	Immunochemical, Thyroglobulin Autoantibody	Immunology	Class 2	866.5870	2024-10-30
MHI	Giardia Spp.	Microbiology	Class 2	866.3220	2017-12-15
LCS	Radioimmunoassay, Digoxin (125-I)	Clinical Toxicology	Class 2	862.3320	2017-12-18
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2017-12-15
DDN	Beta-2-Glycoprotein I, Antigen, Antiserum, Control	Immunology	Class 1	866.5430	2016-05-20
MDU	Antigen, Elisa, Cryptococcus	Microbiology	Class 2	866.3165	2016-05-20
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2017-12-18
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2017-12-18
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2017-12-18
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2017-12-18
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2017-12-18
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2017-12-18
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2017-12-18
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2017-12-18
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2017-12-18
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2017-12-18
LFY	Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster	Microbiology	Class 2	866.3900	2025-06-05
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2022-05-20
CFL	Radioimmunoassay, Human Growth Hormone	Clinical Chemistry	Class 1	862.1370	2016-05-20
GMP	Antisera, Control For Nontreponemal Tests	Microbiology	Class 2	866.3820	2023-08-10
NOP	Elisa, Antibody, West Nile Virus	Microbiology	Class 2	866.3940	2017-12-17
LLA	Direct Agglutination Test, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2019-08-26
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2021-06-07
DDC	Thyroglobulin, Antigen, Antiserum, Control	Immunology	Class 2	866.5870	2008-04-18
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2020-11-20
DRR	Amplifier And Signal Conditioner, Biopotential	Cardiovascular	Class 2	870.2050	2008-04-21
JRY	Antiserum, Fluorescent, Epstein-Barr Virus	Microbiology	Class 1	866.3235	2008-04-21
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2008-04-21
DCN	System, Test, C-Reactive Protein	Immunology	Class 2	866.5270	2023-08-10
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2023-06-18
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2008-04-22
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2008-04-22
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2008-04-22
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2008-04-22
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2008-04-22
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2008-04-22
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2008-04-22
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2008-04-22
JJR	Electrolyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-04-22
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2008-04-22
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2008-11-13
LIP	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	Microbiology	Class 2	866.3830	2016-07-27
MXB	Test, Vaginal, Bacterial Sialidase	Microbiology	Class 1	866.2660	2022-08-30
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2016-07-27
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2023-06-05
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2016-07-27
DAM	Hemoglobin, Chain Specific, Antigen, Antiserum, Control	Immunology	Class 2	866.5470	2022-06-06
GPF	Antigen, Agglutinating, Echinococcus Spp.	Microbiology	Class 1	866.3200	2017-12-17
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2017-04-10
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2008-04-21
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	Class 2	866.5100	2008-04-17
DHC	System, Test, Systemic Lupus Erythematosus	Immunology	Class 2	866.5820	2023-08-10
LJC	Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)	Microbiology	Class 1	866.3120	2023-06-16
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2023-06-22
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2008-04-22
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2008-04-22
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2008-04-22
CEE	Radioimmunoassay, Thyroxine-Binding Globulin	Clinical Chemistry	Class 2	862.1685	2025-06-05
GNH	Antigen, Fluorescent Antibody Test, Schistosoma Mansoni	Microbiology	Class 1	866.3600	2017-12-15
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Microbiology	Class 2	866.3510	2008-11-13
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2008-04-17
PMT	Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens	Microbiology	Class 2	866.3215	2020-11-20
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2017-12-17
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2017-12-17
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2017-12-17
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2017-12-17
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2017-12-17
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2017-12-17
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2017-12-17
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2017-12-17
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2017-12-17
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2017-12-17
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2017-12-17
NSF	Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment	Immunology	Class 2	866.6030	2017-07-17
JTC	Device, Microtiter Diluting/Dispensing	Microbiology	Class 1	866.2500	2017-12-17
CFP	Radioimmunoassay, Immunoreactive Insulin	Clinical Chemistry	Class 1	862.1405	2016-05-20
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Microbiology	Class 2	866.3510	2008-04-18
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2017-12-17
MGX	Test System, For Drugs Of Abuse	Unknown	Class 3	N/A	2017-04-10
PVA	Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3250	2018-09-26
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2017-12-17
CIZ	Radioimmunoassay, Androstenedione	Clinical Chemistry	Class 1	862.1075	2016-05-20
GNW	Antisera, Cf, Influenza Virus A, B, C	Microbiology	Class 1	866.3330	2018-05-07
JLX	Radioimmunoassay, 17-Hydroxyprogesterone	Clinical Chemistry	Class 1	862.1395	2016-05-20
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2018-06-12
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2025-06-05
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2008-04-18
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2017-12-18
GNC	Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.	Microbiology	Class 2	866.3550	2018-12-10
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2017-12-18
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2025-12-18
LIM	Test, Screening, For D Positive Fetal Rbc'S	Hematology	Class 2	864.7455	2023-06-16
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2017-12-18
DBE	Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5120	2008-04-21
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2008-04-21
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2017-12-18
KTN	System, Test, Infectious Mononucleosis	Immunology	Class 2	866.5640	2023-08-10
LFZ	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	Microbiology	Class 2	866.3175	2025-06-05
JSX	Kit, Identification, Neisseria Gonorrhoeae	Microbiology	Class 1	866.2660	2017-04-10
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2025-06-11
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2025-06-11
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2025-06-11
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2025-06-11
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2025-06-11
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2025-06-11
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2025-06-11
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2025-06-11
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2025-06-11
MPQ	Container, Specimen, Urine, Drugs Of Abuse, Over The Counter	Pathology	Class 1	864.3260	2018-09-26
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2018-05-07
GMQ	Antigens, Nontreponemal, All	Microbiology	Class 2	866.3820	2023-06-18
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2008-11-13
LFZ	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	Microbiology	Class 2	866.3175	2008-11-13
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2023-06-08
LKQ	Antibody Igm,If, Cytomegalovirus Virus	Microbiology	Class 2	866.3175	2008-04-21
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2025-06-05
LSE	Epstein-Barr Virus, Other	Microbiology	Class 1	866.3235	2008-04-21
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2023-06-22
KIY	Chamber, Slide Culture	Hematology	Class 1	864.2240	2008-04-21
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2017-12-18
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2025-06-11
DDC	Thyroglobulin, Antigen, Antiserum, Control	Immunology	Class 2	866.5870	2008-04-18
JHT	Chromatographic Separation, Cpk Isoenzymes	Clinical Chemistry	Class 2	862.1215	2025-06-17
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2021-06-07
DHX	System, Test, Carcinoembryonic Antigen	Immunology	Class 2	866.6010	2017-07-17
LSE	Epstein-Barr Virus, Other	Microbiology	Class 1	866.3235	2017-12-15
MHJ	Cryptosporidium Spp.	Microbiology	Class 2	866.3220	2017-12-19
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2017-12-17
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2017-07-17
MVO	Kit, Test, Multiple, Drugs Of Abuse, Over The Counter	Unknown	Class U	N/A	2017-04-10
MYF	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2	Microbiology	Class 2	866.3305	2017-12-15
MXJ	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1	Microbiology	Class 2	866.3305	2017-12-15
DKE	Reagents, Test, Tetrahydrocannabinol	Clinical Toxicology	Class 2	862.3870	2023-06-22
LFY	Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster	Microbiology	Class 2	866.3900	2017-12-18
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2017-07-05
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Microbiology	Class 1	866.3480	2026-02-10
LLM	Test, Antigen, Nuclear, Epstein-Barr Virus	Microbiology	Class 1	866.3235	2017-12-15
OUY	Trichomonas Vaginalis Nucleic Acid Amplification Test System	Immunology	Class 2	866.3860	2022-11-02
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2018-05-07
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2024-10-30
MHJ	Cryptosporidium Spp.	Microbiology	Class 2	866.3220	2017-12-18
MHI	Giardia Spp.	Microbiology	Class 2	866.3220	2017-12-18
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2008-04-18
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2017-12-17
LFZ	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	Microbiology	Class 2	866.3175	2008-11-13
LGC	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific	Microbiology	Class 2	866.3305	2008-04-18
JLS	Radioimmunoassay, Progesterone	Clinical Chemistry	Class 1	862.1620	2016-05-20
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2017-12-18
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2024-10-30
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2023-08-10
PCL	Enzyme Linked Immunoabsorbent Assay, Rubeola Igm	Microbiology	Class 1	866.3520	2026-01-16
MHJ	Cryptosporidium Spp.	Microbiology	Class 2	866.3220	2008-04-21
LJY	Enzyme Linked Immunoabsorbent Assay, Mumps Virus	Microbiology	Class 1	866.3380	2017-12-15
MGM	C. Trachomatis (Chlamydia Group)	Microbiology	Class 1	866.3120	2018-06-12
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2008-04-21
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2017-12-18
GLZ	Antigens, If, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2008-04-21
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Microbiology	Class 2	866.3510	2025-06-05
GLZ	Antigens, If, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2008-04-21
LHL	Reagents, Antibody, Legionella, Direct & Indirect Fluorescent	Microbiology	Class 2	866.3300	2008-04-21
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2017-12-15
DEL	Lipoprotein X, Antigen, Antiserum, Control	Immunology	Class 1	866.5590	2016-05-20
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2008-04-21
LJC	Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)	Microbiology	Class 1	866.3120	2017-12-17
MTN	Test, Syphilis, Treponemal	Unknown	Class N	N/A	2017-04-10
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2023-10-05
LLM	Test, Antigen, Nuclear, Epstein-Barr Virus	Microbiology	Class 1	866.3235	2008-04-21
QMN	Covid-19 Multi-Analyte Antigen Device	Unknown	Class N	N/A	2024-05-28
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2017-12-18
GRY	Antigens, All, Leptospira Spp.	Microbiology	Class 2	866.3350	2017-12-15
MTF	Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer	Unknown	Class 3	N/A	2017-07-06
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2008-04-18
DBL	Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5660	2008-04-21
GRX	Antisera, All Leptospira Spp.	Microbiology	Class 2	866.3350	2024-06-08
DBM	Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5090	2008-04-21
GQL	Antisera, Fluorescent, Herpesvirus Hominis 1,2	Microbiology	Class 2	866.3305	2008-04-21
LIP	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	Microbiology	Class 2	866.3830	2017-12-15
LJZ	Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.	Microbiology	Class 1	866.3375	2008-04-18
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2008-04-23
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2023-06-22
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2025-06-11
NCD	Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis	Unknown	Class 3	N/A	2017-04-10
MDT	Elisa, Trichinella Spiralis	Microbiology	Class 1	866.3850	2023-09-05
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	2023-08-10
LIB	Device, General Purpose, Microbiology, Diagnostic	Microbiology	Class 1	866.2660	2024-08-04
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2017-12-18
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2023-06-01
MJH	Legionella, Spp., Elisa	Microbiology	Class 2	866.3300	2017-12-15
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2025-06-11
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2025-06-11
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2025-06-11
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2025-06-11
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2025-06-11
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2025-06-11
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2025-06-11
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2025-06-11
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2025-06-11
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2017-12-18
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2017-12-17
MDJ	Reagents, Cysticercosis	Microbiology	Class 1	866.3200	2026-06-03
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Microbiology	Class 2	866.3510	2008-11-13
DBM	Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5090	2008-04-21
JKC	Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	Clinical Chemistry	Class 1	862.1245	2024-10-30
PIQ	Reagents For Detection Of Norovirus Nucleic Acid	Microbiology	Class 2	866.3990	2024-05-06
DFC	Lipoprotein, Low-Density, Antigen, Antiserum, Control	Immunology	Class 2	866.5600	2017-12-18
LIQ	Enzyme Linked Immunoabsorbent Assay, Rotavirus	Microbiology	Class 1	866.3405	2017-12-17
KSX	Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use	Hematology	Class 2	864.9160	2020-10-23
LKV	Enzyme Immunoassay, Fetal Fibronectin	Unknown	Class 3	N/A	2022-08-30
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2025-06-11
OUC	Norovirus Serological Reagent	Microbiology	Class 2	866.3395	2018-05-07
LRM	Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control	Immunology	Class 2	866.5100	2008-04-17
DDC	Thyroglobulin, Antigen, Antiserum, Control	Immunology	Class 2	866.5870	2024-10-30
GQH	Antigen, Cf (Including Cf Control), Cytomegalovirus	Microbiology	Class 2	866.3175	2008-04-21
JWX	Kit, Screening, Staphylococcus Aureus	Microbiology	Class 1	866.2660	2023-09-05
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2021-06-07
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2017-12-18
OHE	Forensic Evidence Sexual Assault Kit	Obstetrics/Gynecology	Class 2	884.1630	2020-03-13
GRX	Antisera, All Leptospira Spp.	Microbiology	Class 2	866.3350	2017-12-15
CGI	Radioimmunoassay, Estriol	Clinical Chemistry	Class 1	862.1265	2016-05-20
MDT	Elisa, Trichinella Spiralis	Microbiology	Class 1	866.3850	2017-12-15
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2017-12-18
PJD	Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device	Clinical Chemistry	Class 2	862.1675	2017-04-10
GQW	Antigen, Cf, (Including Cf Control), Varicella-Zoster	Microbiology	Class 2	866.3900	2008-04-21
LLM	Test, Antigen, Nuclear, Epstein-Barr Virus	Microbiology	Class 1	866.3235	2008-04-18
GPD	Antigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus	Microbiology	Class 1	866.3200	2017-12-17
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2025-06-17
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2008-04-21
QCU	Dengue Virus Antigen Assay	Microbiology	Class 2	866.3945	2025-06-05
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2025-06-11
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2008-04-21
KHQ	Radioassay, Triiodothyronine Uptake	Clinical Chemistry	Class 2	862.1715	2017-12-15
MTP	Antibody To Htlv-1, Elisa	Unknown	Class 3	N/A	2016-07-27
LJN	Antibody Igm, If, Epstein-Barr Virus	Microbiology	Class 1	866.3235	2008-04-21
GTZ	Antisera, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2017-04-10
LFY	Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster	Microbiology	Class 2	866.3900	2017-12-18
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2021-05-28
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2025-06-11
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2025-06-11
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2025-06-11
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2025-06-11
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2025-06-11
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2025-06-11
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2025-06-11
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2025-06-11
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2025-06-11
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2025-06-11

Official Correspondent

PAUL SHAW

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Diagnostic Automation /Cortez Diagnostics Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

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Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K930247	The Binding Site, Ltd.	HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE	1993-03-10
K132630	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300)	2013-09-27
K850376	Terumo Medical Corp.	TERUMO SENSIBEAD EIA TSH KIT	1985-03-04
K843395	Hybritech, Inc.	ENCORE TSH REAGENT	1984-10-11
K854087	Organon Teknika Corp.	NML TSH IRMA	1985-10-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2025	Qualigen Inc	2	FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Z-0044-2020	Roche Diagnostics Operations, Inc.	2	AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
Z-0072-2017	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Centaur XPT Immunoassay System
Z-0029-2013	Alere San Diego, Inc.	2	Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.
Z-0006-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2029372. Last updated year: 2026. Please use registration number 2029372 when referencing this establishment in official correspondence.