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BIALEX LAB

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30218410513021841051BIALEX LAB1N2026-01-01717 Ohio Ave Wichita Falls TX US 76301

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3032631719480747K994405INSTANT-VIEW MARIJUANA URINE CASSETTE TESTDKE2000-06-02
3032631823064118K992002AUTOHDL CHOLESTEROL REAGENT SETLBR1999-08-05
3032631548319483K981978AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATORMRR1998-07-22
3032631792708842K972073TOTAL BILIRUBIN REAGENTCIG1997-06-24
3032631291246960K971005TRIGLYCERIDESJGY1997-04-21
3032631287088655K951892ONE STEP URINE DRUG OF ABUSE COCAINE TESTDIO1995-08-17
3032631665773348K931888TOTAL BILIRUBINCIG1993-07-27
3032631884726822K930679DIRECT BILIRUBINCIG1993-06-29
3032631428537331K870928CHOLESTEROL (TOTAL) ANALYSIS PRODUCTSCHH1987-04-22
3032631770087689K870365DIRECT BILIRUBIN REAGENT - ACID DIAZO METHODCIG1987-08-19
3032631283021147K855194GLUCOSE OXIDASE REAGENT SETCGA1986-01-14
3032631497561281K813495ALT (SGPT)CKA1981-12-31
3032631196138298K813405AST(SGOT) IN VITRO DIAG. REAGENT SETCIT1981-12-22
3032631583794150K813366AMMONIA TESTJID1981-12-22
3032631182193896K812794LIPASECET1981-10-20
3032631301143597K792551ALKALINE PHOSPHATASE REAGENTCJH1980-01-29
3032631451414896K123586EASYRA CREATININE REAGENTCGX2013-05-15
3032631344105392K082001DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116BJII2008-12-05
3032631487994575K072142S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST ASTCKF2008-06-26
3032631801044311K070017PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPSNBW2007-01-31
3032631754309929K050283CREATININE LIQUICOLORJFY2005-06-30
3032632027848347K042318AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SETJJY2004-12-09
3032631109206631K042191DIAZYME POTASSIUM ENZYMATIC ASSAY KITMZV2004-10-29
3032631455701602K042189DIAZYME SODIUM ENZYMATIC ASSAYMZU2004-10-07
3032631958307627K033899LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITORNFX2004-05-20
3032631828266228K023550WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDAKNK2002-12-09
3032631754465029K021636ALBUMIN REAGENTCJW2002-07-17
3032631337726145K012065WIENER LAB. CREATININA CINETICA AAJFY2001-10-10
3032631011558883
3032631054576960
3032631076270993
3032631103513770
3032631104369396
3032631131306445
3032631180030222
3032631180877798
3032631255580615
3032631286866978
3032631304060489
3032631320822825
3032631324081888
3032631374430461
3032631403660812
3032631418847941
3032631440244891
3032631443652732
3032631494202584
3032631559987049
3032631568799092
3032631612564674
3032631633339032
3032631656586993
3032631725612696
3032631734222916
3032631775196251
3032631776862052
3032631777858350
3032631785898103
3032631807204166
3032631813447669
3032631816331813
3032631830191321
3032631855982586
3032631863226922
3032631874356680
3032631895963542
3032631907756849
3032631923086260
3032631931808415
3032631971506659
3032631994299485
3032632004287647
3032632009705228
3032632016339116

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CIG51997-06-24
CKF22008-06-26
JFY22005-06-30
JJY22004-12-09
MZV22004-10-29
MZU22004-10-07
KNK22002-12-09
CJW22002-07-17
JGY21997-04-21
CHH21987-04-22
CGA21986-01-14
CKA21981-12-31
CIT21981-12-22
CET21981-10-20
CJH21980-01-29
CGX12013-05-15
JII12008-12-05
NBW12007-01-31
NFX12004-05-20
DKE12000-06-02
LBR11999-08-05
MRR11998-07-22
DIO11995-08-17
JID11981-12-22