Scanostics UTI Check Application Test System
Teco Diagnostics
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1832216 | 1832216 | TECO DIAGNOSTICS | 1 | Y | 2026-01-01 | 1268 NORTH LAKEVIEW AVE. ANAHEIM CA US 92807 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10673486014037 | Teco 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. | 7144631111 | hello@tecodiagnostics.com |
| 10673486014044 | Teco 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 analyzers | 7144631111 | hello@tecodiagnostics.com |
| 10673486014051 | Teco 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. | 7144631111 | hello@tecodiagnostics.com |
| 10673486014068 | Teco 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. | 7144631111 | hello@tecodiagnostics.com |
| 10673486014105 | Teco Diagnostics Hema Stain - Teco Diagnostics Hema Stain is a biological stain for in vitro diagnostic use. | 7144631111 | hello@tecodiagnostics.com |
| 10673486014112 | Teco Diagnostics TC-TROL (N) Serum Control Level I Human - Teco Diagnostics TC-TROL (N) Serum Control Level I Human is for monitoring the accuracy and precision of assay procedures commonly used in clinical chemistry. For in vitro diagnostic use. | 7144631111 | hello@tecodiagnostics.com |
| 10673486014129 | Teco Diagnostics TC-TROL (A) Serum Control Level II Human - Teco Diagnostics TC-TROL (A) Serum Control Level II Human is for monitoring the accuracy and precision of assay procedures commonly used in clinical chemistry. For in vitro diagnostic use. | 7144631111 | hello@tecodiagnostics.com |
| 10673486014136 | Teco Diagnostics TC Chemistry Calibrator I - Teco Diagnostics TC Chemistry Calibrator I is for monitoring the accuracy and precision of assay procedures used commonly in clinical chemistry. For in vitro diagnostic use. | 7144631111 | hello@tecodiagnostics.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 33412 | 1879420790 | K994093 | AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C | LCL | 1999-12-16 |
| 33412 | 1045291596 | K992528 | BIOCHECK IGE ELISA, MODEL BC-1035 | DGC | 1999-09-21 |
| 33412 | 1596913902 | K992517 | BIOCHECK FERRITIN ELISA MODEL BC-1025 | DBF | 1999-09-24 |
| 33412 | 1376424828 | K991741 | BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 | JHI | 1999-07-22 |
| 33412 | 1330978862 | K991432 | BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 | KLI | 1999-06-02 |
| 33412 | 1781736244 | K991311 | TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 | CDP | 1999-06-02 |
| 33412 | 1923510222 | K990993 | BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003 | JLW | 1999-06-22 |
| 33412 | 1859811206 | K982938 | QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODEL 9153 | DJR | 1999-02-05 |
| 33412 | 1689683085 | K982634 | DRYSPOT INFECTIOUS MONONUCLEOSIS KIT | KTN | 1999-01-28 |
| 33412 | 1035188216 | K981687 | QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1 | JXM | 1998-06-03 |
| 33412 | 1776877337 | K981650 | AST/SGOT LIQUID REAGENT - KINETIC METHOD | CIT | 1998-06-29 |
| 33412 | 1942353875 | K981650 | AST/SGOT LIQUID REAGENT - KINETIC METHOD | CIT | 1998-06-29 |
| 33412 | 1085143077 | K981106 | UREA NITROGEN (BUN) LIQUID REAGENT | CDQ | 1998-04-16 |
| 33412 | 1373592005 | K980865 | QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071, 9076, 9081 AND 9131 | DKZ | 1998-04-01 |
| 33412 | 1482462007 | K974059 | ONE STEP MIDSTREAM HCG PREGNANCY TEST | LCX | 1998-04-09 |
| 33412 | 1521141762 | K972619 | QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080) | DJG | 1997-08-20 |
| 33412 | 1664963328 | K970579 | ONE STEP MORPHINE CARD TEST | DNK | 1997-07-03 |
| 33412 | 1330103515 | K970548 | ONE STEP MARIJUANA CARD TEST | LDJ | 1997-07-03 |
| 33412 | 1387665806 | K970250 | CLINISTRIP | JIL | 1997-04-08 |
| 33412 | 1686928480 | K970250 | CLINISTRIP | JIL | 1997-04-08 |
| 33412 | 1295327709 | K964536 | ONE-STEP DIPSTICK PREGNANCY TEST | JHI | 1997-02-11 |
| 33412 | 1891787712 | K964462 | ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST | JHI | 1997-02-11 |
| 33412 | 1003192099 | K964461 | ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST | JHI | 1997-02-11 |
| 33412 | 1145779418 | K962019 | C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST | DCK | 1996-11-25 |
| 33412 | 2004816655 | K962015 | RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST | DHR | 1996-11-25 |
| 33412 | 1344254025 | K961864 | CSF/URINE TOTAL PROTEIN | CEK | 1996-10-24 |
| 33412 | 1462630833 | K961629 | THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST | JLW | 1996-09-11 |
| 33412 | 1832347382 | K960733 | MINISTICK PREGNANCY TEST | LCX | 1996-05-01 |
| 33412 | 1510490820 | K955438 | URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION) | JIR | 1996-01-29 |
| 33412 | 1363707140 | K954977 | URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) | JRE | 1996-03-11 |
| 33412 | 1642611349 | K943436 | URINE REAGENT STRIPS-8 PARAMETERS | JJB | 1995-04-24 |
| 33412 | 1026027906 | K942735 | CARBON DIOXIDE (C02) | KHS | 1995-03-20 |
| 33412 | 1291362441 | K942735 | CARBON DIOXIDE (C02) | KHS | 1995-03-20 |
| 33412 | 2021023571 | K942648 | IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET | JIL | 1995-03-24 |
| 33412 | 1064191832 | K941427 | SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) | JMK | 1995-03-13 |
| 33412 | 1755827016 | K940469 | URINE REAGENT STRIP-3 PARAMETERS | JIL | 1994-09-09 |
| 33412 | 1845267017 | K936245 | MULTI ANALYTE LINEARITY SET | JJY | 1994-10-04 |
| 33412 | 1591468234 | K936031 | ONE STEP PREGNANCY TEST | JHI | 1994-04-15 |
| 33412 | 1478899185 | K932551 | ACCUTEX IM LATEX TEST | KTN | 1993-08-09 |
| 33412 | 1934071811 | K931183 | GLYCOHEMOGLOBIN | LCP | 1993-11-05 |
| 33412 | 1140256540 | K931080 | AMYLASE REAGENT SET (KINETIC) | JFJ | 1993-11-05 |
| 33412 | 1215654836 | K924248 | ACCUTEX SLE LATEX TEST | LJM | 1992-11-02 |
| 33412 | 1761949460 | K923376 | VISUAL HCG PREGNANCY TEST | JHI | 1992-10-01 |
| 33412 | 1114086572 | K922723 | TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL | GTQ | 1992-09-18 |
| 33412 | 1028707787 | K915710 | AMYLASE (COLORIMETRIC) REAGENT SET | JFJ | 1992-01-30 |
| 33412 | 1241915257 | K915709 | CREATINE KINASE-MB (CK-MB) REAGENT SET | CGS | 1992-01-27 |
| 33412 | 1128952029 | K915708 | INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET | CEO | 1992-01-22 |
| 33412 | 1293937003 | K915706 | LIPASE REAGENT SET | CET | 1992-02-18 |
| 33412 | 1910658583 | K915705 | ACID PHOSPHATASE REAGENT SET | CKE | 1992-02-27 |
| 33412 | 1662935477 | K914171 | IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE | DIH | 1991-12-18 |
| 33412 | 1225802605 | K914160 | CHOLESTEROL REGEANT SET | CHH | 1992-01-30 |
| 33412 | 2036190623 | K914159 | GLUCOSE REAGENT SET | CGA | 1992-01-27 |
| 33412 | 1084406340 | K914158 | URIC ACID REAGENT SET | KNK | 1992-02-21 |
| 33412 | 1337395488 | K910185 | SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZER | JJE | 1991-04-03 |
| 33412 | 1347536349 | K905098 | ELEGANCE GH ELISA | CFL | 1990-12-06 |
| 33412 | 1240464160 | K902574 | POTASSIUM REAGENT SET | CEJ | 1990-07-10 |
| 33412 | 1952600730 | K902572 | SODIUM REAGENT SET | CEI | 1990-07-10 |
| 33412 | 1514865936 | K902495 | ACID PHOSPHATASE REAGENT SET | CKB | 1990-07-16 |
| 33412 | 1082252590 | K901561 | IRON/TOTAL IRON BINDING CAPACITY | JIY | 1990-05-17 |
| 33412 | 1301784101 | K900224 | STAT FAX(TM)-2100 | JJQ | 1990-03-01 |
| 33412 | 1882261039 | K883683 | HEMOGLOBIN | GJZ | 1988-10-06 |
| 33412 | 1669024599 | K883387 | ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) | CKD | 1988-10-13 |
| 33412 | 1928453324 | K883386 | CHLORIDE | CHJ | 1988-10-06 |
| 33412 | 1963827471 | K882938 | STAT FAX(TM) | JJQ | 1988-09-09 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JIL | 17 | 2016-07-22 |
| DKZ | 12 | 2014-05-14 |
| JHI | 11 | 1999-07-22 |
| DIO | 8 | 2012-02-01 |
| LCP | 8 | 2005-08-08 |
| CGA | 7 | 2012-04-24 |
| CGS | 6 | 2008-04-18 |
| JXM | 6 | 2006-07-28 |
| LDJ | 6 | 2006-06-06 |
| CIT | 6 | 1998-06-29 |
| JJW | 6 | 1984-10-05 |
| NBW | 5 | 2017-04-21 |
| KHE | 5 | 2011-01-28 |
| JMT | 4 | 2017-09-21 |
| LCX | 4 | 2015-10-02 |
| JJE | 4 | 2008-05-08 |
| JIR | 4 | 2007-01-26 |
| DJG | 4 | 2006-06-15 |
| LBR | 4 | 2005-07-26 |
| JFJ | 4 | 2004-05-10 |
| DCK | 4 | 2001-07-20 |
| CFR | 4 | 2000-02-08 |
| CJE | 4 | 2000-01-20 |
| JLW | 4 | 1999-06-22 |
| KTN | 4 | 1999-01-28 |
| CEK | 4 | 1996-10-24 |
| JJY | 4 | 1994-10-04 |
| KNK | 4 | 1992-02-21 |
| CHH | 4 | 1992-01-30 |
| JJQ | 4 | 1990-03-01 |
| CFH | 4 | 1988-03-16 |
| GMQ | 4 | 1987-03-10 |
| MMI | 3 | 2004-11-19 |
| CDQ | 3 | 1998-04-16 |
| KHS | 3 | 1995-03-20 |
| CEO | 3 | 1992-01-22 |
| CIG | 3 | 1988-06-07 |
| CDT | 3 | 1988-03-15 |
| JFY | 2 | 2016-03-07 |
| DIC | 2 | 2011-10-04 |
Teco Diagnostics
TECO DIAGNOSTICS, INC.
Teco Diagnostics, Inc.
TECO DIAGNOSTICS, INC.
TECO DIAGNOSTICS, INC.
TECO DIAGNOSTICS
TECO DIAGNOSTICS
TECO DIAGNOSTICS
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