FDA.reportPublic FDA data

Horiba-Instruments-Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18278211827821HORIBA INSTRUMENTS INCORPORATED1N2026-01-015449 Research Dr Canton MI US 48188
20867253002698356HORIBA INSTRUMENTS INCORPORATED1Y2026-01-019755 Research Dr IRVINE CA US 92618
20867253002698356HORIBA INSTRUMENTS INCORPORATED1Y2020-04-259755 Research Dr IRVINE CA US 92618

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
00811727015150Pointe Scientific, Inc. Toxoplasma IgG - Pointe Scientific, Inc. Toxoplasma IgG Reagent is for the qualitative, semi-quantitative or quantitative detection of human IgG antibodies to Toxoplasma gondii in human serum by enzyme immunoassay, as an aid in the determination of infection with Toxoplasma. When used as a qualitative test, Toxoplasma IgG EIA aids in the assessment of the patient's immunological response to toxoplasma. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests800-445-9853techservice@medtest.com
00811727015167Pointe Scientific, Inc. Toxoplasma IgM - Pointe Scientific, Inc. Toxoplasma IgM Reagent is for the qualitative and quantitative detection of human IgM antibodies to Toxoplasma in human serum by enzyme immunoassay, to aid in the diagnosis of Toxoplasma infection. A positive result is presumptive for the detection of anti-Toxoplasma gondii antibodies and presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection. Patient testing with anti-Toxoplasma gondii IgM antibody assay, must be accompanied by an anti-Toxoplasma gondii IgG antibody assay. The assay’s performance characteristics have not been established for neonatal toxoplasmosis diagnosis. This assay has not been cleared / approved by the FDA for blood / plasma donor screening. 96 tests.800-445-9853techservice@medtest.com
00811727015174Pointe Scientific, Inc. Rubella IgG - Pointe Scientific, Inc. Rubella IgG is for the qualitative, semi-quantitative and quantitative detection of human IgG antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the assessment of the patient's immunological response to rubella, and as a qualitative screening test to determine the immune status of individuals, including women of childbearing age. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests800-445-9853techservice@medtest.com
00811727015181Pointe Scientific, Inc. Rubella IgM - Pointe Scientific, Inc. Rubella IgM is for the qualitative detection of human IgM antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the diagnosis of rubella infection. A positive result is presumptive for the detection of anti-rubella IgM antibodies and presumptive for the diagnosis of acute or recent rubella infection. 96 tests800-445-9853techservice@medtest.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2990241286342609K993853K-ASSAY MULTI-ANALYTE CALIBRATORJIX1999-12-27
2990241523746296K993537K-ASSAY TRANSFERRINDDG1999-11-30
2990241651792598K992528BIOCHECK IGE ELISA, MODEL BC-1035DGC1999-09-21
2990241817798355K992517BIOCHECK FERRITIN ELISA MODEL BC-1025DBF1999-09-24
2990241204038312K992002AUTOHDL CHOLESTEROL REAGENT SETLBR1999-08-05
2990241399209338K991741BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027JHI1999-07-22
2990241655218319K991432BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007KLI1999-06-02
2990241755677661K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005CDP1999-06-02
2990242057815437K991146TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001JLW1999-06-22
2990241797621765K990993BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003JLW1999-06-22
2990242051369372K983241ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYSJJY1998-09-29
2990241140604614K983130LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYSJJY1998-09-29
2990241541392331K982485SERAQUEST CMV IGMLFZ1999-01-13
2990241383242956K982281SERAQUEST RUBELLA IGMLFX1998-10-16
2990241874252791K981978AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATORMRR1998-07-22
2990241095257323K980907AXIS HOMOCYSTEINE ENZYME IMMUNOASSAYLPS1998-10-16
2990241930030682K973589LIQUID LDH-L REAGENT SETCFJ1997-10-08
2990241540749743K973588LIQUID ALKALINE PHOSHATASE REAGENT SETCJE1997-10-22
2990242008577228K973157LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SETJQB1997-10-10
2990241168330337K972725ALCOHOL REAGENT SETDIC1997-09-25
2990241978621003K972671BUN (LIQUID) REAGENT SETCDQ1997-07-20
2990241281338112K971672SERAQUEST TOXOPLASMA IGMLGD1997-10-21
2990241273670205K970781LIQUID GLUCOSE (OXIDASE) REAGENT SETCGA1997-04-21
2990241713485304K970560URIC ACID (LIQUID) REAGENT SETKNK1997-03-11
2990241477999053K963282SERAQUEST HSV IGGLGC1997-01-22
2990241852192660K961431LACTATE DEHYDROGENASE REAGENT SETCFJ1996-06-03
2990241449237836K961282GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60CFR1996-06-21
2990241325195437K961053SERAQUEST RUBELLA IGGLFX1996-09-04
2990241655333291K960092SERAQUEST TOXOPLASMA IGGLGD1996-06-17
2990241926629644K954191SERAQUEST CMV IGGLFZ1996-02-23
2990241271111186K954074AALTO SCIENTIFIC LIQUID CARDIAC CONTROLJJY1995-10-07
2990241354659142K951749BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3JJY1995-05-15
2990241114484299K942958CREATINE KINASE MB DETERMINATION (UV)JHW1994-11-21
2990241511534438K941287LIQUID ALT(SGPT) REAGENT SETCKA1994-05-03
2990241764930713K941132LIQUID AST (SGOT)REAGENT SETCIT1994-05-02
2990241044847828K940735LIQUID AMYLASE (CNPG3) REAGENT SETCIJ1994-08-01
2990241386524575K921625CALCIUM-ARSENAZO III REAGENT SETCIC1992-05-13
2990241062721338K920449POINTE 750 GLYCOMETERLCP1992-07-28
2990241525227664K910108GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIEDJIN1991-03-04
2990241534248404K897150LIPASE COLOR [TOYO] SERUM LIPASE TEST KITCHI1990-02-26
2990241948189887K891117HDL CHOLESTEROL REAGENTLBR1989-04-10
2990241013842577K882117ETHYL ALCOHOL STANDARDDNN1988-08-04
2990241131378769K864882FERROZINE (COLORIMETRIC) IRON BINDING CAPACITYJIY1987-01-21
2990241835968053K864706RAICHEM(TM) AMMONIA REAGENTJIF1987-01-05
2990241744892627K863832NAPHTHYL PHOSPHATE, ACID PHOSPHATASEJFH1986-12-16
2990241007407765K862033TRIGLYCERIDESCDT1986-07-22
2990241370051169K860572GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SETLCP1986-05-16
2990241157613923K860257DIRECT BILIRUBINCIG1986-02-21
2990242066065796K860154BUN (ENZYMATIC BERTHELOT) REAGENT SETCDL1986-02-06
2990241427990322K853592MAGNESIUMJGJ1985-09-16
2990241643303498K851432HEMOGLOBINKHG1985-07-12
2990241080118357K832870DIAZO COLORIMETRY, BILLIRUBINCIG1983-09-26
2990241645471721K831863CHOLESTEROL-ENZYMATIC REAGENT SETCHH1983-07-22
2990241639306290K831526URINE TOTAL PROTEIN CONTROLJJW1983-08-12
2990241954267406K830556CREATININECGX1983-03-24
2990241841848653K822471PSI ALBUMIN REAGENTCIX1982-09-14
2990242036903842K822470PSI INORGANIC PHOSPHORUSCEO1982-09-14
2990241878217097K822469PSI CALCIUM REAGENTCIC1982-09-14
2990241396356242K822468PSI TOTAL PROTEIN REAGENTCEK1982-09-14
2990241785869999K812574HDL CHOLESTEROL REAGENTLBR1981-09-24
2990242058729154K812452ALKALINE PHOSPHATASECJE1981-09-09
2990241982764528K812430URIC ACID REAGENT SETKNK1981-09-09
2990241345523778K812341UREA NITROGEN (BUN)CDQ1981-09-01
2990241102231888K810680ENZYMATIC TRIGLYCERIDECDT1981-03-31
2990241320735387K810674GLUCOSE OXIDASECGA1981-03-31
2990241805431227K810673ENZYMATIC CHOLESTEROLCHH1981-03-31
2990242003693651K800780SANDARE LYOPHILIZED HEMOGLOBIN CONTROLSJPK1980-04-24
2990241809311044K192727K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)DHR2020-05-20
2990242010286454K191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayDIO2020-03-12
2990241392457476K191296Pointe Scientific Creatinine Kinase (CK) Reagent SetCGS2020-08-11
2990241836465220K181159LZI Fentanyl Enzyme ImmunoassayDJG2018-12-03
2990241383523741K180074Diazyme Lipoprotein (a) AssayDFC2018-03-22
2990241856861007K171476SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)JGS2018-02-27
2990241707693577K160370BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry AnalyzerJGS2016-06-09
2990241292288593K141055LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML)DJG2014-06-13
2990241304725999K140690BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZERCDQ2014-09-02
2990241522831826K133710LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLSDKB2014-02-21
2990241339591971K132711CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENTLBS2014-05-08
2990241768815659K131556DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SETJIT2013-06-26
2990241388172038K121232K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATORDBF2012-05-24
2990241566531423K120763LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLSDJG2012-06-01
2990241858358843K120761LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLSDJG2012-05-08
2990241456555679K113661LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLSLAF2012-01-23
2990241628732550K113139LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLSDIO2011-11-22
2990241971417777K110298OPIATE ENZYME IMMUNOASSAYDJG2011-07-15
2990241059696142K110239LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLLDJ2011-06-23
2990241020608793K102210LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLSDKZ2010-12-28
2990241745992793K1011956-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLSDJG2010-07-06
2990241257427209K090844BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLSDJG2009-07-30
2990241248578472K083222AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100LPS2009-07-31
2990241603300281K072018BS-200 CHEMISTRY ANALYZER, MODE BS-200CFR2008-02-01
2990241604670524K071388GENTIAN CYSTATIN C IMMUNOASSAYNDY2007-11-06
2990241150032927K070757MICROPROTEIN REAGENT SETJGP2007-12-04
2990241303004849K070504AMMONIA/ALCOHOL CONTROL SETJJY2007-04-11
2990242028465589K070251CARBON DIOXIDE LIQUID STABLE REAGENTKHS2007-04-30
2990241081789543K070207MULTI-ANALYTE CHEMISTRY CALIBRATORJIX2007-04-13
2990241557271039K052148TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SETJIT2005-11-09
2990241577451057K050283CREATININE LIQUICOLORJFY2005-06-30
2990242041501694K042318AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SETJJY2004-12-09
2990241741891820K040391TOTAL BILIRUBIN REAGENT SETCIG2004-06-02
2990241258722149K033094ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)DKZ2003-12-19
2990241931912303K032764BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)DIS2003-11-03
2990241775456035K032461ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221DIC2003-10-03
2990241286358152K032365BENZODIAZEPINE ENZYME IMMUNOASSAYJXM2003-09-05
2990241631252820K031797METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)DJR2003-10-10
2990241516016289K031539HEMOGLOBIN A1C REAGENT SETLCP2003-08-06
2990241782369257K024006G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASEJBF2003-03-31
2990241846322641K023860MICROALBUMIN REAGENT SET AND CALIBRATORSDDZ2003-04-28
2990241302858599K023828K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBRDCK2003-02-04
2990241725399898K023795PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)JXN2003-01-21
2990241816317134K023396AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)CIJ2002-12-23
2990241467520846K023317METHADONE ENZYME IMMUNOASSAYDJR2002-12-12
2990242013171915K023316SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLSDLJ2002-12-16
2990241305442343K022660BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117DRR2002-12-19
2990242070879399K020769SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLSDLJ2002-04-03
2990241572555659K020763COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT)DIO2002-05-10
2990241567322748K020548FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300CEC2002-04-05
2990241992105809K020395AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT)DKZ2002-06-04
2990241982292600K020254PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011LCM2002-05-10
2990241817444968K013698AST (SGOT)CIT2001-12-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DJG72018-12-03
JJY62007-04-11
CDQ42014-09-02
DIO32020-03-12
DKZ32010-12-28
CIG32004-06-02
LCP32003-08-06
LBR31999-08-05
JGS22018-02-27
JIT22013-06-26
DBF22012-05-24
LPS22009-07-31
CFR22008-02-01
KHS22007-04-30
JIX22007-04-13
DJR22003-10-10
DIC22003-10-03
DCK22003-02-04
CIJ22002-12-23
DLJ22002-12-16
CIT22001-12-21
JLW21999-06-22
LFZ21999-01-13
LFX21998-10-16
CJE21997-10-22
LGD21997-10-21
CFJ21997-10-08
CGA21997-04-21
KNK21997-03-11
CIC21992-05-13
CDT21986-07-22
CHH21983-07-22
CGS12020-08-11
DHR12020-05-20
QBK12018-04-20
DFC12018-03-22
LBS12014-05-08
DKB12014-02-21
LAF12012-01-23
LDJ12011-06-23

GUDID#

Pointe Scientific, Inc. HSV-1 & 2 IgG - Pointe Scientific, Inc. HSV-1 & 2 IgG Reagent is for the qualitative, and semi-quantitative detection of human IgG antibodies to type 1 and type 2 herpes simplex virus (HSV) in human serum by enzyme immunoassay. To aid in the evaluation of the patient's immunological history with HSV, including women of childbearing age. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests.

HORIBA INSTRUMENTS INCORPORATED

2016-08-31

Pointe Scientific, Inc. CMV IgM - Pointe Scientific, Inc. CMV IgM Reagent is for the qualitative detection of human IgM antibodies to cytomegalovirus (CMV) in human serum by enzyme immunoassay, to aid in the diagnosis of CMV infection. A positive result is presumptive for the detection of anti-CMV IgM antibodies and presumptive for the diagnosis of acute or recent CMV infection. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests.

HORIBA INSTRUMENTS INCORPORATED

2016-08-31

Pointe Scientific, Inc. CMV IgG - Pointe Scientific, Inc. CMV IgG Reagent is for the detection of human IgG antibodies to cytomegalovirus virus in human serum by enzyme immunoassay, as an aid in the determination of acute or reactivated infection with CMV. When used as a qualitative test, CMV IgG EIA aids in the assessment of the patient's immunological response to CMV. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests

HORIBA INSTRUMENTS INCORPORATED

2016-08-31

Pointe Scientific, Inc. Rubella IgG - Pointe Scientific, Inc. Rubella IgG is for the qualitative, semi-quantitative and quantitative detection of human IgG antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the assessment of the patient's immunological response to rubella, and as a qualitative screening test to determine the immune status of individuals, including women of childbearing age. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests

HORIBA INSTRUMENTS INCORPORATED

2016-08-31

Pointe Scientific, Inc. Toxoplasma IgM - Pointe Scientific, Inc. Toxoplasma IgM Reagent is for the qualitative and quantitative detection of human IgM antibodies to Toxoplasma in human serum by enzyme immunoassay, to aid in the diagnosis of Toxoplasma infection. A positive result is presumptive for the detection of anti-Toxoplasma gondii antibodies and presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection. Patient testing with anti-Toxoplasma gondii IgM antibody assay, must be accompanied by an anti-Toxoplasma gondii IgG antibody assay. The assay’s performance characteristics have not been established for neonatal toxoplasmosis diagnosis. This assay has not been cleared / approved by the FDA for blood / plasma donor screening. 96 tests.

HORIBA INSTRUMENTS INCORPORATED

2016-08-31

Pointe Scientific, Inc. Toxoplasma IgG - Pointe Scientific, Inc. Toxoplasma IgG Reagent is for the qualitative, semi-quantitative or quantitative detection of human IgG antibodies to Toxoplasma gondii in human serum by enzyme immunoassay, as an aid in the determination of infection with Toxoplasma. When used as a qualitative test, Toxoplasma IgG EIA aids in the assessment of the patient's immunological response to toxoplasma. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests

HORIBA INSTRUMENTS INCORPORATED

2016-08-31

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