FDA.reportPublic FDA data

MedTest Dx

Matched from indexed company URL: Medtest DX

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18278211827821MedTest Dx1N2020-04-255449 RESEARCH DRIVE Canton Twp MI US 48188

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
00817439020314C1 Cleaning Solution - For use as a cleaning solution on the Polychem 180 System. Concentrate formula. Use according to package instructions. 6 x 10 ml800-445-9853techservice@medtest.com
00817439020321Calibrator Level 1 - For use as a Calibrator in clinical chemistry assays. Calibration Serum Level 1 is based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays on a wide range of automatic analyzers. Constituent concentrations are available at 1 level.800-445-9853techservice@medtest.com
00817439020338Calibration Serum Level 2 - For use as a calibrator in clinical chemistry assays.800-445-9853techservice@medtest.com
00817439020345Calcium / BS480 - For the quantitative determination of Calcium in serum or heparinized plasma using the Mindray BS-480 analyzer. 6 x 60 ml.800-445-9853techservice@medtest.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
332751735882784K993590FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SETLCP1999-12-21
332751025557834K992528BIOCHECK IGE ELISA, MODEL BC-1035DGC1999-09-21
332751951343563K992517BIOCHECK FERRITIN ELISA MODEL BC-1025DBF1999-09-24
332751250963416K992002AUTOHDL CHOLESTEROL REAGENT SETLBR1999-08-05
332751847265065K991741BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027JHI1999-07-22
332751386866638K991432BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007KLI1999-06-02
332751525817555K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005CDP1999-06-02
332751603660129K991146TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001JLW1999-06-22
332752007135494K990993BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003JLW1999-06-22
332751335216699K982485SERAQUEST CMV IGMLFZ1999-01-13
332751845164437K982281SERAQUEST RUBELLA IGMLFX1998-10-16
332751774302037K981978AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATORMRR1998-07-22
332751960596299K980907AXIS HOMOCYSTEINE ENZYME IMMUNOASSAYLPS1998-10-16
332752041477307K973589LIQUID LDH-L REAGENT SETCFJ1997-10-08
332751537497780K973588LIQUID ALKALINE PHOSHATASE REAGENT SETCJE1997-10-22
332751032224116K973157LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SETJQB1997-10-10
332751747064024K972725ALCOHOL REAGENT SETDIC1997-09-25
332751965456661K972671BUN (LIQUID) REAGENT SETCDQ1997-07-20
332751369674057K972155CREATINE KINASE (CK)CGS1997-07-17
332751941664695K971672SERAQUEST TOXOPLASMA IGMLGD1997-10-21
332751218385779K970781LIQUID GLUCOSE (OXIDASE) REAGENT SETCGA1997-04-21
332751709080239K970560URIC ACID (LIQUID) REAGENT SETKNK1997-03-11
332751975006077K963282SERAQUEST HSV IGGLGC1997-01-22
332752071322622K961431LACTATE DEHYDROGENASE REAGENT SETCFJ1996-06-03
332751817765912K961282GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60CFR1996-06-21
332751706665091K961053SERAQUEST RUBELLA IGGLFX1996-09-04
332751456565522K960092SERAQUEST TOXOPLASMA IGGLGD1996-06-17
332751348086980K955489CALIBRATION SERUM LEVEL 1 & 2JIX1996-06-21
332751267900098K954191SERAQUEST CMV IGGLFZ1996-02-23
332751886756714K954074AALTO SCIENTIFIC LIQUID CARDIAC CONTROLJJY1995-10-07
332751520240259K952720AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & IIJPK1995-09-20
332751957689986K951749BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3JJY1995-05-15
332752060942874K942958CREATINE KINASE MB DETERMINATION (UV)JHW1994-11-21
332751656051110K942458PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATEDJJY1995-03-13
332751407787041K941132LIQUID AST (SGOT)REAGENT SETCIT1994-05-02
332751266363938K940735LIQUID AMYLASE (CNPG3) REAGENT SETCIJ1994-08-01
332751572694469K921625CALCIUM-ARSENAZO III REAGENT SETCIC1992-05-13
332751875150254K921206HCG CONTROLJJX1992-04-29
332751125871907K920449POINTE 750 GLYCOMETERLCP1992-07-28
332751937445994K910108GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIEDJIN1991-03-04
332751363405497K897150LIPASE COLOR [TOYO] SERUM LIPASE TEST KITCHI1990-02-26
332751012799250K891117HDL CHOLESTEROL REAGENTLBR1989-04-10
332751895803090K882938STAT FAX(TM)JJQ1988-09-09
332751502814108K882117ETHYL ALCOHOL STANDARDDNN1988-08-04
332751764868398K882059BILIRUBIN STANDARDJIT1988-10-25
332751022666927K874131CRESOLPHTHALEIN COMPLEXONE, CALCIUMCIC1987-12-04
332751700417979K864882FERROZINE (COLORIMETRIC) IRON BINDING CAPACITYJIY1987-01-21
332751057130803K864706RAICHEM(TM) AMMONIA REAGENTJIF1987-01-05
332751895110389K863832NAPHTHYL PHOSPHATE, ACID PHOSPHATASEJFH1986-12-16
332751619617179K862033TRIGLYCERIDESCDT1986-07-22
332751192131925K860572GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SETLCP1986-05-16
332751277625173K860257DIRECT BILIRUBINCIG1986-02-21
332751911667381K860154BUN (ENZYMATIC BERTHELOT) REAGENT SETCDL1986-02-06
332751244213491K853592MAGNESIUMJGJ1985-09-16
332751351561312K852169CHLORIDE REAGENTCHJ1985-08-21
332751023680164K851432HEMOGLOBINKHG1985-07-12
332751063625400K832872HEXOKINASE, GLUCOSECFR1983-10-14
332751703390088K832870DIAZO COLORIMETRY, BILLIRUBINCIG1983-09-26
332751775491238K831526URINE TOTAL PROTEIN CONTROLJJW1983-08-12
332751345391659K830556CREATININECGX1983-03-24
332751627512692K822471PSI ALBUMIN REAGENTCIX1982-09-14
332751114348698K822470PSI INORGANIC PHOSPHORUSCEO1982-09-14
332751261941656K822469PSI CALCIUM REAGENTCIC1982-09-14
332752027249130K822468PSI TOTAL PROTEIN REAGENTCEK1982-09-14
332751105116223K813496LDH-LCFJ1981-12-31
332751194270623K813495ALT (SGPT)CKA1981-12-31
332751815365618K813406CPK(CK) IN VITRO DIAG. REAGENT SETJHS1981-12-22
332751511176272K813405AST(SGOT) IN VITRO DIAG. REAGENT SETCIT1981-12-22
332751668854798K812574HDL CHOLESTEROL REAGENTLBR1981-09-24
332751569926759K812452ALKALINE PHOSPHATASECJE1981-09-09
332751830323678K812430URIC ACID REAGENT SETKNK1981-09-09
332751314825765K812341UREA NITROGEN (BUN)CDQ1981-09-01
332751764326070K812296GAMMA GLUTAMY TRANSPEPTIDASEJQB1981-08-31
332751334288279K810680ENZYMATIC TRIGLYCERIDECDT1981-03-31
332751226863190K810674GLUCOSE OXIDASECGA1981-03-31
332751156489080K810673ENZYMATIC CHOLESTEROLCHH1981-03-31
332751507165929K800780SANDARE LYOPHILIZED HEMOGLOBIN CONTROLSJPK1980-04-24
332751250432146K180074Diazyme Lipoprotein (a) AssayDFC2018-03-22
332752017422888K171476SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)JGS2018-02-27
332751529849709K160370BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry AnalyzerJGS2016-06-09
332751475814795K140690BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZERCDQ2014-09-02
332751816761133K132711CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENTLBS2014-05-08
332751928366907K131556DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SETJIT2013-06-26
332751725828149K083222AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100LPS2009-07-31
332751958514431K072018BS-200 CHEMISTRY ANALYZER, MODE BS-200CFR2008-02-01
332751741868084K070757MICROPROTEIN REAGENT SETJGP2007-12-04
332751172698656K070504AMMONIA/ALCOHOL CONTROL SETJJY2007-04-11
332751918801694K070251CARBON DIOXIDE LIQUID STABLE REAGENTKHS2007-04-30
332751644136811K070207MULTI-ANALYTE CHEMISTRY CALIBRATORJIX2007-04-13
332751791716632K062808LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENTLPS2006-10-13
332751645569007K061056RANDOX LIQUID PROTEIN CALIBRATORJIX2006-07-20
332751933275318K052148TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SETJIT2005-11-09
332751789581493K051646ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGHJGS2005-10-07
332751095620477K050283CREATININE LIQUICOLORJFY2005-06-30
332751255365107K042318AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SETJJY2004-12-09
332751118832900K040391TOTAL BILIRUBIN REAGENT SETCIG2004-06-02
332751135862900K031608RANDOX LIQUID PROTEIN CALIBRATORJIX2003-08-08
332751660572021K031539HEMOGLOBIN A1C REAGENT SETLCP2003-08-06
332751216893719K024006G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASEJBF2003-03-31
332752039418038K024006G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASEJBF2003-03-31
332751868720691K023860MICROALBUMIN REAGENT SET AND CALIBRATORSDDZ2003-04-28
332751036312193K023828K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBRDCK2003-02-04
332751464943908K023654GLYCA-DIRECT FRUCTOSAMINELCP2003-05-02
332751825252902K023396AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)CIJ2002-12-23
332751301527208K022660BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117DRR2002-12-19
332751419057521K022591RANDOX LIPID CONTROLJJY2002-08-30
332751840816937K020548FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300CEC2002-04-05
332751997522092K013062BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KITMMI2002-01-08
332752011333930K012332JAS CARBON DIOXIDE LIQUID REAGENTKHS2001-09-06
332751054824225K011568RANDOX LIPOPROTEINJIS2001-09-28
332751617354988K002651C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SETDCK2000-10-13
332751249785229K002294BIOCHECK TESTOSTERONE EIA, MODEL BC-1115CDZ2000-10-02
332751273528022K000781DIRECT TIBC KITJMO2000-05-02
332751090443992
332751112492981
332751157549043
332751210726175
332751226152246
332751328422774
332751346224353

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JJY62007-04-11
LCP52003-08-06
JIX42007-04-13
JGS32018-02-27
CDQ32014-09-02
JIT32013-06-26
LPS32009-07-31
CFR32008-02-01
CIG32004-06-02
LBR31999-08-05
CFJ31997-10-08
CIC31992-05-13
KHS22007-04-30
JBF22003-03-31
DCK22003-02-04
CIJ22002-12-23
JLW21999-06-22
LFZ21999-01-13
LFX21998-10-16
CJE21997-10-22
LGD21997-10-21
JQB21997-10-10
CGA21997-04-21
KNK21997-03-11
JPK21995-09-20
CIT21994-05-02
CDT21986-07-22
DFC12018-03-22
LBS12014-05-08
JGP12007-12-04
JFY12005-06-30
DDZ12003-04-28
DRR12002-12-19
CEC12002-04-05
MMI12002-01-08
JIS12001-09-28
CDZ12000-10-02
JMO12000-05-02
DBF11999-09-24
DGC11999-09-21

PMN#

GUDID#

72 records. Showing 1-40. Next