FDA.reportPublic FDA data

AMS DIAGNOSTICS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30091285553009128555AMS DIAGNOSTICS1N2020-04-251790 N Commerce Pkwy Weston FL US 33326

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1275621692504773K993590FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SETLCP1999-12-21
1275621237339518K993481K-ASSAY C4DBI1999-11-29
1275621560875249K993437K-ASSAY C3CZW1999-11-24
1275621171779098K993323K-ASSAY IGMCFF1999-11-30
1275621818557333K993281K-ASSAY IGGDEW1999-11-09
1275621102861486K993213K-ASSAY IGACFF1999-11-23
1275621447690227K972671BUN (LIQUID) REAGENT SETCDQ1997-07-20
1275621133550710K972155CREATINE KINASE (CK)CGS1997-07-17
1275621016006616K970560URIC ACID (LIQUID) REAGENT SETKNK1997-03-11
1275621875201175K961588TOTAL IRON (NITRO-PAPS) REAGENT SETJIY1996-11-18
1275621619554938K941315STANBIO Y-GT (LIQUICOLOR) TEST SETJQB1994-07-14
1275621030622120K941313STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SETCJE1994-05-17
1275622060040060K941287LIQUID ALT(SGPT) REAGENT SETCKA1994-05-03
1275621787768770K941132LIQUID AST (SGOT)REAGENT SETCIT1994-05-02
1275621982091401K921625CALCIUM-ARSENAZO III REAGENT SETCIC1992-05-13
1275621198549384K914873DIAZO COLORIMETRY, BILIRUBINCIG1991-12-04
1275621569563658K871781ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SETCFJ1987-06-03
1275621910391603K864882FERROZINE (COLORIMETRIC) IRON BINDING CAPACITYJIY1987-01-21
1275621355704879K862033TRIGLYCERIDESCDT1986-07-22
1275621761489838K853592MAGNESIUMJGJ1985-09-16
1275621316651064K832870DIAZO COLORIMETRY, BILLIRUBINCIG1983-09-26
1275621402183991K822471PSI ALBUMIN REAGENTCIX1982-09-14
1275621099012916K822470PSI INORGANIC PHOSPHORUSCEO1982-09-14
1275621206940741K812794LIPASECET1981-10-20
1275621684628721K810673ENZYMATIC CHOLESTEROLCHH1981-03-31
1275621778472243K131556DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SETJIT2013-06-26
1275621109696410K120763LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLSDJG2012-06-01
1275621592403676K120761LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLSDJG2012-05-08
1275621265703143K113661LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLSLAF2012-01-23
1275621388071914K113139LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLSDIO2011-11-22
1275622073435727K113131LIASYS 450CFR2012-03-08
1275622045056526K110298OPIATE ENZYME IMMUNOASSAYDJG2011-07-15
1275621373405630K110239LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLLDJ2011-06-23
1275621527371589K102210LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLSDKZ2010-12-28
1275621929701340K1011956-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLSDJG2010-07-06
1275621681657686K090844BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLSDJG2009-07-30
1275621040325134K080468LIASYS WITH MODELS LIASYSCFR2008-07-25
1275621309963127K073488DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXXMSJ2008-03-07
1275621990998425K072523DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLSLBR2008-01-22
1275621155923730K072395DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLSLBS2008-01-03
1275621019926472K071971DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CALLPS2007-09-17
1275621987884084K070757MICROPROTEIN REAGENT SETJGP2007-12-04
1275621493828361K070251CARBON DIOXIDE LIQUID STABLE REAGENTKHS2007-04-30
1275621679958064K062105DIAZYME CREATININE LIQUID REAGENTS ASSAYJFY2007-04-23
1275621528881937K051088MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLSDKB2005-06-24
1275621516731951K050733OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLSDJG2005-06-13
1275621609108793K033885BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT)DIS2004-05-19
1275621756541054K033866CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS)DIO2004-04-07
1275621636187577K033094ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)DKZ2003-12-19
1275621783444359K032764BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)DIS2003-11-03
1275621098529790K032461ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221DIC2003-10-03
1275621190031220K032365BENZODIAZEPINE ENZYME IMMUNOASSAYJXM2003-09-05
1275621661878068K031797METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)DJR2003-10-10
1275621219316888K031539HEMOGLOBIN A1C REAGENT SETLCP2003-08-06
1275621238903182K023860MICROALBUMIN REAGENT SET AND CALIBRATORSDDZ2003-04-28
1275621520478133K023795PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)JXN2003-01-21
1275621698283567K023396AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)CIJ2002-12-23
1275621098200335K023317METHADONE ENZYME IMMUNOASSAYDJR2002-12-12
1275621884734747K023316SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLSDLJ2002-12-16
1275621500864050K021887CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071LDJ2002-08-15
1275621536407892K021449CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLSDLJ2002-06-18
1275621757681167K002651C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SETDCK2000-10-13
1275621244445720K002199MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SETCFR2000-11-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DJG62012-06-01
CFR32012-03-08
DIO22011-11-22
LDJ22011-06-23
DKZ22010-12-28
DIS22004-05-19
DJR22003-10-10
LCP22003-08-06
DLJ22002-12-16
CFF21999-11-30
JIY21996-11-18
CIG21991-12-04
JIT12013-06-26
LAF12012-01-23
MSJ12008-03-07
LBR12008-01-22
LBS12008-01-03
JGP12007-12-04
LPS12007-09-17
KHS12007-04-30
JFY12007-04-23
DKB12005-06-24
DIC12003-10-03
JXM12003-09-05
DDZ12003-04-28
JXN12003-01-21
CIJ12002-12-23
DCK12000-10-13
DBI11999-11-29
CZW11999-11-24
DEW11999-11-09
CDQ11997-07-20
CGS11997-07-17
KNK11997-03-11
JQB11994-07-14
CJE11994-05-17
CKA11994-05-03
CIT11994-05-02
CIC11992-05-13
CFJ11987-06-03

PMN#