FDA Registration Active 🇺🇸 United States

TECO DIAGNOSTICS

Reg #: 1832216 · FEI: 1832216 · Expires 2026
Products
121
Proprietary Names
244
Establishment Types
5
Classifications
121

Registration Details

Registration Name
TECO DIAGNOSTICS
Registration Number
1832216
FEI Number
1832216
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
1268 NORTH LAKEVIEW AVE.
City
ANAHEIM
State
CA
ZIP
92807
Country
US

Regulatory Submissions

510(k) Number
K864905

Owner / Operator

Firm Name
TECO DIAGNOSTICS
Operator Number
1832216
Address
1268 NORTH LAKEVIEW AVE., --
City
Anaheim
State
CA
Postal Code
92807
Country
US
Correspondent
KC Chen

Products

Device Name Product Code
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes CJE
Test, Follicle Stimulating Hormone (Fsh), Over The Counter NGA
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes CGS
Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
Enzyme Immunoassay, Amphetamine DKZ
Assay, Glycosylated Hemoglobin LCP
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
Kinetic Method, Gamma-Glutamyl Transpeptidase JQB
Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes CIO
Enzymatic, Carbon-Dioxide KHS
Acid, Uric, Uricase (Colorimetric) KNK
Visual, Pregnancy Hcg, Prescription Use JHI
Tetraphenyl Borate, Colorimetry, Potassium CEJ
Station, Pipetting And Diluting, For Clinical Use JQW
Immunoassay Method, Troponin Subunit MMI
Devices, Breath Trapping, Alcohol DJZ
Multi-Analyte Controls, All Kinds (Assayed) JJY
Antigens, Nontreponemal, All GMQ
System, Test, Beta-2-Microglobulin Immunological JZG
Nadh Oxidation/Nad Reduction, Ast/Sgot CIT
Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
Enzyme Immunoassay, Opiates DJG
Thin Layer Chromatography, Methamphetamine DJC
Reagents, Test, Tetrahydrocannabinol DKE
Enzyme Immunoassay, Phencyclidine LCM
Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
Hexokinase, Glucose CFR
Ferrozine (Colorimetric) Iron Binding Capacity JMO
Photometric Method, Iron (Non-Heme) JIY
Enzymatic Method, Creatinine JFY
Ige, Antigen, Antiserum, Control DGC
Kit, Test, Multiple, Drugs Of Abuse, Over The Counter MVO
System, Test, Rheumatoid Factor DHR
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
Refractometer For Clinical Use JRE
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
Blood, Occult, Colorimetric, In Urine JIO
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine KLI
Alkaline Picrate, Colorimetry, Creatinine CGX
Colorimetry, Cholinesterase DIH
Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen JNF
Colorimetric Method, Cpk Or Isoenzymes JHY
Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
Calibrator, Primary JIS
Urease And Glutamic Dehydrogenase, Urea Nitrogen CDQ
System, Test, Blood Glucose, Over The Counter NBW
Glucose Oxidase, Glucose CGA
Nadh Oxidation/Nad Reduction, Alt/Sgpt CKA
Cresolphthalein Complexone, Calcium CIC
System, Test, C-Reactive Protein DCN
Olive Oil Emulsion (Turbidimetric), Lipase CET
Ldl & Vldl Precipitation, Hdl LBR
Berthelot Indophenol, Urea Nitrogen CDL
Urinalysis Controls (Assayed And Unassayed) JJW
Kit, Screening, Urine JXA
Enzyme Immunoassay, Cannabinoids LDJ
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
Multiple Use Blood Lancet For Single Patient Use Only QRL
Reagent, Occult Blood KHE
Enzyme Immunoassay, Methadone DJR
Enzyme Immunoassay, Benzodiazepine JXM
Gas Chromatography, Methamphetamine LAF
Enzyme Immunoassay, Barbiturate DIS
Radioimmunoassay, Luteinizing Hormone CEP
System, Test, Systemic Lupus Erythematosus DHC
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides CDT
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase CFJ
Thin Layer Chromatography, Morphine DNK
Radioimmunoassay, Testosterones And Dihydrotestosterone CDZ
Radioimmunoassay, Total Triiodothyronine CDP
Acid Phosphatase, Thymolphthale Inmonophosphate CKE
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
Calibrator, Multi-Analyte Mixture JIX
Bromcresol Green Dye-Binding, Albumin CIX
Automated Urinalysis System KQO
Test, Urine Leukocyte LJX
C-Reactive Protein, Antigen, Antiserum, And Control DCK
Radioimmunoassay, Phencyclidine LCL
Amplifier And Signal Conditioner, Biopotential DRR
Biuret (Colorimetric), Total Protein CEK
Electrolyte Controls (Assayed And Unassayed) JJR
Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase CFH
Activated Partial Thromboplastin GFO
Phosphomolybdate (Colorimetric), Inorganic Phosphorus CEO
Kit, Test, Pregnancy, Hcg, Over The Counter LCX
Colorimeter, Photometer, Spectrophotometer For Clinical Use JJQ
Photometric Method, Magnesium JGJ
System, Test, Infectious Mononucleosis KTN
Catalytic Methods, Amylase JFJ
Radioimmunoassay, Thyroid-Stimulating Hormone JLW
Diazo, Ast/Sgot CIQ
Radioimmunoassay, Follicle-Stimulating Hormone CGJ
Antistreptolysin - Titer/Streptolysin O Reagent GTQ
System, Test, Anticardiolipin Immunological MID
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) MSV
Uranyl Acetate/Zinc Acetate, Sodium CEI
Enzymatic Esterase--Oxidase, Cholesterol CHH
Mercuric Thiocyanate, Colorimetry, Chloride CHJ
System, Test, Low Density, Lipoprotein MRR
Diethyldithiocarbamate (Colorimetric), Copper JKZ
Reagent, Coronavirus Serological QKO
Hydrazone Colorimetry, Alt/Sgpt CKD
Diazo Colorimetry, Bilirubin CIG
Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase JMK
Sulfophosphovanillin, Colorimetry, Total Lipids CFD
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method DIC
Plasma, Coagulation Control GGN
Radioimmunoassay, Human Growth Hormone CFL
Radioimmunoassay, Prolactin (Lactogen) CFT
Helicobacter Pylori LYR
Fluorometry, Morphine DJJ
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls LJM
Cyanomethemoglobin Reagent And Standard Solution GJZ
Qualitative Chemical Reactions, Urinary Calculi (Stone) JNQ
Acid Phosphatase, Naphthyl Phosphate CKB
Ferritin, Antigen, Antiserum, Control DBF

Proprietary Names

ALKALINE PHOSPHATASE Teco Menopause Stage Indicator FSH Test CK-MB (NAC), Kinetic Amphetamine Card/Dipstick Test Glycohemoglobin URINE REAGENT STRIP-3 GAMMA-GLUTAMYL TRANSPEPTIDASE AND ISOENZYMES TEST SYSTEM CLIAWAIVED URS-1G JorVet URS-1G Pulse Scientific Inc URS-1G Cortez Diagnostics URS-1G LW Scientific URS-1G IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET Alkaline Phosphatase Color CARBON DIOXIDE (CO2) URIC ACID hCG Microtiter Test POTASSIUM REAGENT SET TC-94/96/PLUS Elisa Washer/Reader Troponin I Card Test AlcoCheck Breath Alcohol Test CK-MB 2 Level Control RAPID PLASMA REAGIN (RPR) SET beta-2 Microglobulin Microtiter Test Carbon Dioxide AST/SGOT LIQUID REAGENT - KINETIC METHOD VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE Multiple Drug Scan -5 Cocaine Dipstick Test Glucose, Hexokinase. Liquid Iron/TIBC URS-1M Microalbumin IgE EIA Kit Uric Acid Drug Scan 2 - MDMA/MET Panel IDG RF Cortez RF Rheumatoid Factor (RF) Cortez URS-9 LW Scientific URS-9 URINE REAGENTS STRIPS-9 Nurse Hatty URS-1K KETO MOJO URS-1K URINE REAGENT STRIP-IK (URS-IK) T4/Free T4 Microtiter Test Creatinine, Color, End Point Cholinesterase, Kinetic URS-PBG Creatine Kinase, Color, End Point HbA1c DIRECT ENZYMATIC TEST KIT BUN, Kinetic Gluco Check Basic ALT/SGPT NADH OXIDATION/NAD REDUCTION, ALT/SGPT TROPONIN I EIA KIT TROPONIN I Gluco-Track Calcium CRESOLPHTHALEIN COMPLEXONE, CALCIUM CRP RAPID TEST C-REACTIVE PROTEIN RAPID TEST LIPASE REAGENT SET HDL Cholesterol UREA NITROGEN(BUN), COLORIMETRIC METHOD BUN, Urease, Color, End Point Urine Controls Human Urine level I (Dried) URINE REAGENT STRIPS Marijuana (THC) Dipstick Test URS-2GP (GLUCOSE PROTEIN) URINE STRIPS VISUAL HCG PREGNANCY TEST One-step combo pregnancy dipstick test ONE STEP MARIJUANA CARD TEST Glucopad TC-Smart+ Lancets Opiates Card Test Drug Scan 6 REAGENT, OCCULT BLOOD Drug Scan 5 - COC/AMP/OPI/PCP/THC Panel Drug Scan 4 - Four Parameter Panel Drug Scan 3 - THC/OPI/BZD Panel Drug Scan 9 - Nine Parameter Panel Drug Scan 8 - Eight Parameter Panel Drug Cup - Multi-Screen 10 Drug Scan 10 - Ten Parameter Panel COC Cocaine Card AMP Amphetamine Card Drug Scan 7 - Seven Parameter Panel THC Marijuana Card BAR Barbiturates Card Drug Scan 5 - MET/AMP/THC/COC/OPI Panel PCP Phencyclidine Card LH Elisa Test kit SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) Triglyceride, GPO LACTATE DEHYDROGENASE LDH-L ONE STEP MORPHINE CARD TEST Testosterone Microtitier Test BZD Benzodiazepine Card BZD Benzodiazepine Dipstick Drug Scan 6 Test Amphetamine Card Test Total T3 Elisa Test kit ACID PHOSPHATASE REAGENT SET TC-Matrix Chemistry Analyzer URITEK TC-101 URINE ANALYZER C-Reactive protein (CRP) IDG CRP Cortez CRP Glycohemoglobin Normal Control Glycohemoglobin Elevated Control MYOGLOBIN EIA KIT Glucopad TC-Smart+ Blood Glucose Monitoring System TOTAL PROTEIN (BIURET) REAGENT SET DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR CLINISTRIP Barbiturate Card/Dipstick Test LACTATE DEHYDROGENASE (LDH-L) URISTAT UTI test strips Teco Diagnostics UTI Test Strips AZO UTI test strips URS-2L Glucose Hexokinase ACTIVATED PARTIAL THROMBOPLASTIN PHOSPHORUS (INORGANIC) Benzodiazepine Card Test Pregnancy HCG test midstream GLUCOSE REAGENT SET TC-3300 Analyzer system MAGNESIUM Cliawaived 10SG URS-5OB-100 URS-2P-100 URS-10 Drug Cup - Multi-Screen 10 with Adulteration Strip Drug Cup - Multi-Screen 3 - AMP/COC/OXY INFECTIOUS MONONUCLEOSIS (IML) IDG RPR Cortez RPR Rapid Plasma Reagent (RPR) Copper Control level I Copper Control level II Amylase, Kinetic AST (SGOT) , Kinetic URITEK TC-101 U-TSH Microtiter AST(SGOT) Color Kinetic FSH ELISA Test Kit Uritek TC-201 Urine Chemistry Test System URS-1G (GLUCOSE TEST) Phencyclidine (PCP) Card Test HEMOGLOBIN A1C REAGENT SET, CONTROL AND CALIBRATOR MET Methamphetamine Card Infectious Mononucleosis (IM) Cortez IML Marijuana (THC) Card Test ANTISTREPTOLYSIN (ASO) BLOOD GLUCOSE MONITORING SYSTEM Tyiglyceride GPO liquid URITEK-720+ URINE ANALYZER TRIGLYCERIDES (GPO-TRINDER) TC-84 analyzer system UREA NITROGEN (BUN) LIQUID REAGENT, KINETIC METHOD MTD Methadone Card CSF/URINE TOTAL PROTEIN Sodium Glucose, Oxidase Cholesterol, Kinetic Liquid CK- NAC, Kinetic Liquid Creatine Kinase - NAC, Kinetic Chloride T3/Free T3 Microtiter Test LACTATE DEHYDROGENASE EXPRESS CLINICAL CHEMISTRY ANALYZER LW Scientific URS-1B URS-1B ALT (SGPT) Kinetic DIRECT LDL CHOLESTEROL COPPER REAGENT SET BIURET (COLORIMETRIC), TOTAL PROTEIN Cortez Diagnostics URS-2K URS-2K ATHENESE URS-2K KISH URS-2K Pulse Scientific Inc URS-2K Cocaine Card Test SARS-CoV-2 IgM & IgG Test System CHOLESTEROL (LIQUID) REAGENT SET ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL ALT(SGPT), Color, End Point ASPARTATE AMINOTRANSFERASE AST/SGOT Gluco Check Smart Fecal Occult Blood Test AMYLASE LIQUID REAGENT Bilirubin, Direct Bilirubin, Direct and Total Bilirubin, Total HIGH SENSITIVITY C-REACTIVE PROTEIN EIA TEST KIT HS CRP HBDH - Kinetic ONE STEP PREGNANCY CARD TEST Total Lipid reagent kit Scanostics UTI Check Application Test System TC-84+ Analyzer system LDH-L LACTATE DEHYDROGENASE-L ONE-STEP DIPSTICK PREGNANCY TEST Teco Saliva Alcohol Test TSH Microtiter Test Urine control Level I, II, III URITEK TC-201 URINE CHEMISTRY TEST SYSTEM BILIRUBIN (DIRECT) COAGULATION CONTROL TC Calibrator - I TC Calibrator - II TC Abnormal Serum Control (Human) TC Normal Serum Control (Human) CLINISTRIP 10 SGL HGH EIA Kit PROLACTIN ELISA Test Kit Alkaline Phosphatase, Liquid Albumin URINE REAGENT STRIPS-8 TC-Thunderbolt automated urine analyzer system Helicobacter Pylori Card Test Inorganic Phosphorus, UV Inorganic Phosphorus, Color OPI Opiates Card Systematic Lupus Erthematosus (SLE) TC-96 Analyzer system Urine Controls Human Urine Level III (Dried) LDH-L, Kinetic Liquid LDH-L Kinetic Hemoblobin Teco Rapid Fecal Occult Blood (FOB) Card Test URS-1K GGT, Kinetic Liquid GGT, Kinetic TECO URINARY CALCULI TEST STRIPS One-step urine/serum pregnancy card test ONE STEP MIDSTREAM HCG PREGNANCY TEST AMYLASE (COLORIMETRIC) REAGENT SET Acid Phosphatase, Kinetic CREATINE KINASE LIQUID REAGENT FERRITIN FERRITIN EIA KIT

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Device in the United States for Export Only