TECO DIAGNOSTICS

Matched from indexed company URL: 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#

200 records. Showing 1-40. Next