FDA.reportPublic FDA data

TECO DIAGNOSTICS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18322161832216TECO DIAGNOSTICS1Y2026-01-011268 NORTH LAKEVIEW AVE. ANAHEIM CA US 92807

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10673486013993Teco Diagnostics Rapid Fecal Occult Blood (FOB) Test - Teco Diagnostics Rapid Fecal Occult Blood (FOB) Test is an immune-chromatographic assay intended for the determination of human hemoglobin in feces by professional laboratories or physician’s offices.7144631111hello@tecodiagnostics.com
10673486014006Teco Diagnostics One-Step Pregnancy Dipstick Test - The Teco Diagnostics One-Step Pregnancy Dipstick Test is used for the rapid determination of human chorionic gonadotropin (hCG) in human urine to obtain a visual qualitative result for the early detection of pregnancy.7144631111hello@tecodiagnostics.com
10673486014013Teco Diagnostics Chemistry Calibrator - Teco Diagnostics Chemistry Calibrator is intended for the calibration of quantitative assays on automated and semi-automated analyzers.7144631111hello@tecodiagnostics.com
10673486014020Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Dipstick Test - Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Dipstick Test is a colloidal gold antibody complex based immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine. This test is for professional use in obtaining a visual qualitative result for the early detection of pregnancy.7144631111hello@tecodiagnostics.com
10673486014037Teco Diagnostics Creatinine (Kinetic) Reagent Kit for TC-Matrix-240 - Teco Diagnostics Creatinine (Kinetic) Reagent Kit for TC-Matrix-240 is used for the quantitative determination of creatinine concentration in serum or plasma on TC Matrix analyzers.7144631111hello@tecodiagnostics.com
10673486014044Teco Diagnostics Creatinine (Kinetic) Reagent Kit for TC-Matrix-480 - Teco Diagnostics Creatinine (Kinetic) Reagent Kit for TC-Matrix-480 is used for the quantitative determination of creatinine concentration in serum or urine on TC Matrix analyzers7144631111hello@tecodiagnostics.com
10673486014051Teco Diagnostics Anti-Streptolysin O (ASO) Reagent Set - Teco Diagnostics Anti-Streptolysin O (ASO) Reagent Set is for the qualitative and semi-quantitative measurement of antibodies to streptococcal exoenzymes in human serum.7144631111hello@tecodiagnostics.com
10673486014068Teco Diagnostics Infectious Mononucleosis (IM) Latex Test - Teco Diagnostics Infectious Mononucleosis (IM) Latex Test is a manual latex agglutination slide test intended to be used for the qualitative and semi-quantitative determination of human heterophile antibodies (HE) associated with IM in human serum.7144631111hello@tecodiagnostics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
334121879420790K994093AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25CLCL1999-12-16
334121045291596K992528BIOCHECK IGE ELISA, MODEL BC-1035DGC1999-09-21
334121596913902K992517BIOCHECK FERRITIN ELISA MODEL BC-1025DBF1999-09-24
334121376424828K991741BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027JHI1999-07-22
334121330978862K991432BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007KLI1999-06-02
334121781736244K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005CDP1999-06-02
334121923510222K990993BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003JLW1999-06-22
334121859811206K982938QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODEL 9153DJR1999-02-05
334121689683085K982634DRYSPOT INFECTIOUS MONONUCLEOSIS KITKTN1999-01-28
334121035188216K981687QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1JXM1998-06-03
334121776877337K981650AST/SGOT LIQUID REAGENT - KINETIC METHODCIT1998-06-29
334121942353875K981650AST/SGOT LIQUID REAGENT - KINETIC METHODCIT1998-06-29
334121085143077K981106UREA NITROGEN (BUN) LIQUID REAGENTCDQ1998-04-16
334121373592005K980865QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071, 9076, 9081 AND 9131DKZ1998-04-01
334121482462007K974059ONE STEP MIDSTREAM HCG PREGNANCY TESTLCX1998-04-09
334121521141762K972619QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080)DJG1997-08-20
334121664963328K970579ONE STEP MORPHINE CARD TESTDNK1997-07-03
334121330103515K970548ONE STEP MARIJUANA CARD TESTLDJ1997-07-03
334121387665806K970250CLINISTRIPJIL1997-04-08
334121686928480K970250CLINISTRIPJIL1997-04-08
334121295327709K964536ONE-STEP DIPSTICK PREGNANCY TESTJHI1997-02-11
334121891787712K964462ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TESTJHI1997-02-11
334121003192099K964461ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TESTJHI1997-02-11
334121145779418K962019C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TESTDCK1996-11-25
334122004816655K962015RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TESTDHR1996-11-25
334121344254025K961864CSF/URINE TOTAL PROTEINCEK1996-10-24
334121462630833K961629THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TESTJLW1996-09-11
334121832347382K960733MINISTICK PREGNANCY TESTLCX1996-05-01
334121510490820K955438URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION)JIR1996-01-29
334121363707140K954977URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)JRE1996-03-11
334121642611349K943436URINE REAGENT STRIPS-8 PARAMETERSJJB1995-04-24
334121026027906K942735CARBON DIOXIDE (C02)KHS1995-03-20
334121291362441K942735CARBON DIOXIDE (C02)KHS1995-03-20
334122021023571K942648IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SETJIL1995-03-24
334121064191832K941427SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)JMK1995-03-13
334121755827016K940469URINE REAGENT STRIP-3 PARAMETERSJIL1994-09-09
334121845267017K936245MULTI ANALYTE LINEARITY SETJJY1994-10-04
334121591468234K936031ONE STEP PREGNANCY TESTJHI1994-04-15
334121478899185K932551ACCUTEX IM LATEX TESTKTN1993-08-09
334121934071811K931183GLYCOHEMOGLOBINLCP1993-11-05
334121140256540K931080AMYLASE REAGENT SET (KINETIC)JFJ1993-11-05
334121215654836K924248ACCUTEX SLE LATEX TESTLJM1992-11-02
334121761949460K923376VISUAL HCG PREGNANCY TESTJHI1992-10-01
334121114086572K922723TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROLGTQ1992-09-18
334121028707787K915710AMYLASE (COLORIMETRIC) REAGENT SETJFJ1992-01-30
334121241915257K915709CREATINE KINASE-MB (CK-MB) REAGENT SETCGS1992-01-27
334121128952029K915708INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SETCEO1992-01-22
334121293937003K915706LIPASE REAGENT SETCET1992-02-18
334121910658583K915705ACID PHOSPHATASE REAGENT SETCKE1992-02-27
334121662935477K914171IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASEDIH1991-12-18
334121225802605K914160CHOLESTEROL REGEANT SETCHH1992-01-30
334122036190623K914159GLUCOSE REAGENT SETCGA1992-01-27
334121084406340K914158URIC ACID REAGENT SETKNK1992-02-21
334121337395488K910185SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZERJJE1991-04-03
334121347536349K905098ELEGANCE GH ELISACFL1990-12-06
334121240464160K902574POTASSIUM REAGENT SETCEJ1990-07-10
334121952600730K902572SODIUM REAGENT SETCEI1990-07-10
334121514865936K902495ACID PHOSPHATASE REAGENT SETCKB1990-07-16
334121082252590K901561IRON/TOTAL IRON BINDING CAPACITYJIY1990-05-17
334121301784101K900224STAT FAX(TM)-2100JJQ1990-03-01
334121882261039K883683HEMOGLOBINGJZ1988-10-06
334121669024599K883387ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)CKD1988-10-13
334121928453324K883386CHLORIDECHJ1988-10-06
334121963827471K882938STAT FAX(TM)JJQ1988-09-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JIL172016-07-22
DKZ122014-05-14
JHI111999-07-22
DIO82012-02-01
LCP82005-08-08
CGA72012-04-24
CGS62008-04-18
JXM62006-07-28
LDJ62006-06-06
CIT61998-06-29
JJW61984-10-05
NBW52017-04-21
KHE52011-01-28
JMT42017-09-21
LCX42015-10-02
JJE42008-05-08
JIR42007-01-26
DJG42006-06-15
LBR42005-07-26
JFJ42004-05-10
DCK42001-07-20
CFR42000-02-08
CJE42000-01-20
JLW41999-06-22
KTN41999-01-28
CEK41996-10-24
JJY41994-10-04
KNK41992-02-21
CHH41992-01-30
JJQ41990-03-01
CFH41988-03-16
GMQ41987-03-10
MMI32004-11-19
CDQ31998-04-16
KHS31995-03-20
CEO31992-01-22
CIG31988-06-07
CDT31988-03-15
JFY22016-03-07
DIC22011-10-04

PMN#

55 records. Showing 1-40. Next

GUDID#

Teco Diagnostics TC Matrix Clinical Chemistry Analyzer - Teco Diagnostics TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use.The device is intended to duplicate manual analytical procedures by automatically performing various steps such as pipetting, heating, mixing and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes of clinical interest in serum, plasma samples.

TECO DIAGNOSTICS

2025-05-28

Teco Diagnostics TC Matrix Clinical Chemistry Analyzer - Teco Diagnostics TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by automatically performing various steps such as pipetting, heating, mixing and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes of clinical interest in serum, plasma samples.

TECO DIAGNOSTICS

2025-05-28

Teco Diagnostics TC Matrix Clinical Chemistry Analyzer - Teco Diagnostics TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by automatically performing various steps such as pipetting, heating, mixing and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes of clinical interest in serum, plasma samples.

TECO DIAGNOSTICS

2025-05-28

Teco Diagnostics TC Matrix Clinical Chemistry Analyzer - Teco Diagnostics TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by automatically performing various steps such as pipetting, heating, mixing and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes of clinical interest in serum, plasma samples.

TECO DIAGNOSTICS

2025-05-28

Teco Diagnostics Glucopad Blood Glucose Test Strips - Teco Diagnostics Glucopad Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood (from fingertip, forearm, and palm) with the Glucopad Blood Glucose Meter. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use.

TECO DIAGNOSTICS

2024-12-19

Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System - Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System is an in vitro diagnostic device used to automate the urine chemistry analysis using TC-Thunderbolt URS-10 strips. It produces semi-quantitative results of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity, and leukocytes in urine. TC-Thunderbolt URS-10 strips are intended for use only with the TC-Thunderbolt Automated Urine Analyzer System; they are not intended for manual visual reading. This device is for clinical laboratory use only. This device is not for point-of-care use. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function.

TECO DIAGNOSTICS

2024-06-06

Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System - Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System consists of the Uritek TC-720+ Urine Analyzer and the Teco Diagnostics Urine Reagent Strips (URS-10). The Uritek TC-720+ Urine Analyzer is an automated, bench top instrument which is intended for point-of-care, in vitro diagnostic use only and is intended to be used together with the Teco Diagnostics Urine Reagent Strips (URS-10) as a system for the determination of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity, and leukocytes in urine.

TECO DIAGNOSTICS

2024-06-05

Teco Diagnostics Uritek TC-201 Urine Chemistry Test System - Teco Diagnostics Uritek TC-201 Urine Chemistry Test System consists of the Uritek TC-201 Urine Chemistry Analyzer and the Teco Diagnostics Urine Reagent (URS-10) Strips. The Uritek TC-201 urine analyzer is an automated, bench top instrument which is intended for point-of-care, in vitro diagnostic use only and is intended to be used together with the Teco Diagnostics Urine Reagent (URS-10) Strips as a system for semi-quantitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in urine. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function.

TECO DIAGNOSTICS

2024-06-04

200 records. Showing 1-40. Next