FDA.reportPublic FDA data

SANZAY CORPORATION -

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30051463133005146313SANZAY CORPORATION -1N2026-01-011080 NW 163rd Drive Miami Gardens FL US 33169

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
903231560485961K994424DIAMEDIX IS-ANTI-DSDNA TEST SYSTEMLRM2000-02-18
903232063363011K993590FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SETLCP1999-12-21
903231117846327K993294DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEMLKJ1999-10-25
903231915598114K992517BIOCHECK FERRITIN ELISA MODEL BC-1025DBF1999-09-24
903231091182699K991741BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027JHI1999-07-22
903231073625596K991432BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007KLI1999-06-02
903231664654326K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005CDP1999-06-02
903232003420791K991166K-ASSAY MICROALBUMIN CALIBRATOR SETJIX1999-06-10
903231973068252K991146TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001JLW1999-06-22
903231515393047K990993BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003JLW1999-06-22
903232070968294K984045RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYSDHR1999-01-25
903231147343900K983241ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYSJJY1998-09-29
903231079709609K981867IS-VZU IGG TEST SYSTEMLFY1998-09-28
903231324568621K981831IS EBV-EA-D IGG ELISA TEST SYSTEMGNP1999-02-16
903231598028891K981829IS EBV-EBNA-1 IGG ELISA TEST SYSTEMGNP1999-02-16
903231463076583K981812EBV-VCA IGG ELISA TEST SYSTEMLSE1999-03-04
903231042804623K981729IS-RUBELLA IGG TEST SYSTEMLFX1999-01-28
903231273111465K981650AST/SGOT LIQUID REAGENT - KINETIC METHODCIT1998-06-29
903231869493113K981498IS-TOXOPLASMA IGG TEST SYSTEMLGD1998-08-21
903231839972537K981339QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3JJY1998-04-21
903231331803621K981306DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEMLGC1998-09-29
903231124805992K981163DIAMEDIX IS-CMV IGG TEST SYSTEMLFZ1998-09-21
903231610199640K981106UREA NITROGEN (BUN) LIQUID REAGENTCDQ1998-04-16
903231663739846K980759DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEMLLL1998-04-23
903231497929683K974889DIAMEDIX IS-RF TEST SYSTEMDHR1998-03-06
903231583378468K974694IS-DSDNA TEST SYSTEMLRM1998-03-03
903231816487461K974552DIAMEDIX IS-MEASLES IGG TEST SYSTEMLJB1998-01-28
903231727491344K972155CREATINE KINASE (CK)CGS1997-07-17
903231843018678K970250CLINISTRIPJIL1997-04-08
903231115151039K970239IS-ANTI-SCL-70 TEST SYSTEM (720-280)LLL1997-04-08
903231492740403K970238IS-ANTI-SM/RNP (720-270)LLL1997-04-08
903231987460750K970237IS-ANTI-SSB TEST SYSTEM (720-260)LLL1997-04-08
903231442951391K970228IS-ANTI-JO-1 TEST SYSTEMLLL1997-04-08
903231642325397K970220IS-ANTI-SM TEST SYSTEMLLL1997-04-08
903231847868813K970218IS-ANTI-SSA TEST SYSTEMLLL1997-04-08
903231157415592K964461ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TESTJHI1997-02-11
903231708259184K962019C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TESTDCK1996-11-25
903231934277880K962015RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TESTDHR1996-11-25
903231882556293K961864CSF/URINE TOTAL PROTEINCEK1996-10-24
903231174428929K960733MINISTICK PREGNANCY TESTLCX1996-05-01
903231496468983K942735CARBON DIOXIDE (C02)KHS1995-03-20
903231743880711K932551ACCUTEX IM LATEX TESTKTN1993-08-09
903232044566440K931183GLYCOHEMOGLOBINLCP1993-11-05
903231519062254K923767PULSE IM RED CELL TESTKTN1992-10-16
903231251341607K921625CALCIUM-ARSENAZO III REAGENT SETCIC1992-05-13
903231685571440K915709CREATINE KINASE-MB (CK-MB) REAGENT SETCGS1992-01-27
903231485337370K915706LIPASE REAGENT SETCET1992-02-18
903231526646757K914171IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASEDIH1991-12-18
903231562668191K914160CHOLESTEROL REGEANT SETCHH1992-01-30
903231793450610K914159GLUCOSE REAGENT SETCGA1992-01-27
903231968779604K914158URIC ACID REAGENT SETKNK1992-02-21
903231395125129K912020ANTI-DNA MICROASSAYLRM1991-09-23
903231491496871K911679ANTI-JO-1 MICROASSAYLLL1991-09-23
903231249529600K911330LYME IGM MICROASSAYLSR1991-06-10
903231281833950K910899LYME DISEASE MICROASSAYLSR1991-06-10
903231214840422K903961MEASLES IGG MICROASSAYLJB1990-12-28
903231747666760K902915ANTI-SCI-70 MICROASSAYLJM1990-09-06
903231781647652K902574POTASSIUM REAGENT SETCEJ1990-07-10
903231655729887K902572SODIUM REAGENT SETCEI1990-07-10
903231697143900K902495ACID PHOSPHATASE REAGENT SETCKB1990-07-16
903231954454802K901561IRON/TOTAL IRON BINDING CAPACITYJIY1990-05-17
903231989482500K901073ANTI-RNP MICROASSAYLLL1990-03-19
903231184556249K900572LYME IGM MICROASSAYLSR1990-05-02
903231353623994K900241ANTI-SSA MICROASSAY AND ANTI-SSB MICROASSAYLLL1990-02-02
903231673939113K896335CLP GLYCOSYLATED HEMOGLOBIN CONTROL-NRLCP1989-12-11
903231448528896K894894ANTI-SM MICROASSAYLJM1989-08-24
903231970693596K892129EZ COMPLEMENT C4DBI1989-04-14
903231362835086K892127EZ COMPLEMENT C3CZW1989-04-14
903231003211687K892125EZ COMPLEMENT C2CZW1989-04-14
903231162274515K891904EZ COMPLEMENT C1DAC1989-04-14
903232014329616K890843LYME DISEASE MICROASSAYLSR1989-07-25
903232062674541K890642VZV MICROASSAYLFY1989-05-15
903232070464428K890579TSH MICROASSAYJLW1989-03-16
903231211583170K885034T-UPTAKE MICROASSAYCEE1989-02-02
903231595438992K884430SERUM HCG MICROASSAYDHA1988-12-09
903231994423270K884260THYROXINE MICROASSAYKLI1989-02-23
903231314099087K883778RUBELLA IGM MICROASSAYLFX1988-10-25
903231304652492K883386CHLORIDECHJ1988-10-06
903231111059245K881626GAMMA-GLUTAMYL TRANSFERASEJQB1988-05-27
903231248369775K881172BILIRUBIN (DIRECT)CIG1988-06-07
903231847983179K881171PHOSPHORUS (INORGANIC)CEO1988-04-28
903232070655356K880629CREATININECGX1988-03-23
903231512338970K880628TRIGLYCERIDES (GPO-TRINDER)CDT1988-03-15
903231562351010K880176HDL CHOLESTEROL PRECIPITATING REAGENTLBR1988-02-18
903231263686192K875070ALBUMIN, BROMCRESOL GREEN DYE-BINDINGCIX1988-01-11
903231107058085K875069BILIRUBIN (TOTAL)CIG1988-01-11
903231720379443K874848LACTATE DEHYDROGENASE LDH-LCFJ1987-12-18
903231474853978K874847MAGNESIUMJGJ1987-12-18
903231904198984K872560ANTI-DNP MICROASSAYDHN1987-07-21
903231633033249K871832CMV IGM MICROASSAYLKQ1987-08-07
903231538599868K871420HERPES 1 AND 2 MICROASSAYSGGC1987-12-11

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLL101998-04-23
LCP72016-01-29
DHR72002-07-09
LBR52008-01-22
DCK52003-02-04
CGS51997-07-17
LFX42000-08-21
LGD42000-07-07
JJY41998-09-29
CEK41996-10-24
LSR41991-06-10
CIG41988-06-07
KHS32017-06-01
NBW32017-03-21
GKZ32015-08-21
JIL32011-02-04
MID32001-10-26
LRM32000-02-18
JLW31999-06-22
KTN31993-08-09
CIC31992-05-13
KNK31992-02-21
CHJ31988-10-06
JJE22014-05-15
DCF22010-04-29
LBS22008-01-03
JIX22007-04-13
JFJ22004-05-10
DKZ22004-03-08
GFO22002-11-01
GGN22002-07-23
GJS22002-05-15
MSV22002-01-08
MST22001-09-28
JGJ22001-03-23
LGC22000-11-28
CFR22000-02-08
CJE22000-01-20
JHI21999-07-22
KLI21999-06-02