FDA.reportPublic FDA data

Sekisui Diagnostics P.E.I. Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80203163002806809Sekisui Diagnostics P.E.I. Inc.1N2026-01-0170 Watts Avenue CHARLOTTETOWN Prince Edward Island CA C1E 2B9

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1263941358998008K992766N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SETMRR1999-10-18
1263941769703973K981609BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30CIG1998-06-03
1263941436046811K974874BILIRUBIN-SL (TOTAL) ASSAYCIG1998-02-12
1263941010773204K974858PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30CEO1998-01-30
1263941061626481K974003ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30CKA1997-12-05
1263941847557607K974001ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30CIT1997-11-13
1263941487180889K974000Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30JQB1997-11-04
1263941453275169K973999CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30CGS1998-03-11
1263941361901156K973933SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30JIY1997-11-04
1263941822451956K973108TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50CEK1998-03-02
1263941465119423K971573N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SETLBR1997-06-18
1263941502003226K971162LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATORLBS1997-06-16
1263941731380903K963116UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAYJMO1996-08-20
1263941735230703K961587IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25JMO1996-08-27
1263941886289515K961586URIC ACID-SL ASSAY CATALOGUE NO. 237-60KNK1996-07-23
1263941591565093K961282GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60CFR1996-06-21
1263941161967119K961281TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60CDT1996-08-16
1263941505104427K932556AMMONIA ASSAY CAT. NO. 200-02JIF1994-08-02
1263942036637201K932555DC-LINEATE CAT. NO. SE-091JIS1993-08-19
1263941758945736K897150LIPASE COLOR [TOYO] SERUM LIPASE TEST KITCHI1990-02-26
1263941390450725K896073CHOLESTEROL, UNIVERSAL ETCHH1989-12-12
1263941366423700K895873CALCIUM, CATALOGUE NUMBER140-20CJY1989-12-12
1263941330794875K882258DC-LIQUICAL CATALOGUE #SE-030JIX1988-08-30
1263941729503481K875285MULTI-CHEMISTRY LINEARITY STANDARDJIX1988-09-02
1263941303751198K875211GLUCOSE (TRINDER) CAT. # 220-32CGA1988-04-18
1263941739952863K874772DC-TROL LEVEL 1 OR 2JJY1988-01-05
1263941796990553K861095BILIRUBIN ASSAY KIT (TOTAL), CATA. NUMBER 202-04CIG1986-04-21
1263941018960301K861094BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02CIG1986-04-21
1263941378475985K843104ALBUMIN ASSAY KITCIX1984-09-07
1263941674892803K843028TOTAL PROTEIN ASSAY KITCEK1984-08-27
1263941588640932K842160CHOLESTEROL ASSSAY KITCHH1984-08-17
1263941730338134K202644AcetaminophenLDP2022-02-18
1263941523643843K180835SEKURE Acetaminophen L3K AssayLDP2019-02-08
1263941073160253K173206SEKURE HbA1c AssayPDJ2018-07-12
1263941125152610K163078DC-UIBC-CALJIT2016-12-08
1263941826109877K111915MAGNESIUM ASSAYJGJ2011-12-02
1263941851459307K082210TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30CIG2008-12-16
1263941635225387K081938ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30LDP2009-05-01
1263941880144692K070383ENZYMATIC CREATININE ASSAY (265 SERIES)JFY2007-06-22
1263941265500453K063208MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7JGJ2007-01-19
1263941906726500K060140CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250JIT2006-04-24
1263941949738112K060139CRP-ADVANCE ASSAY, MODELS 250-20, 250-25DCK2006-04-28
1263941982011747K051191DCL MICROALBUMIN ASSAY, MODEL 252-20DCF2005-07-05
1263942054806466K042362MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12KHS2004-12-27
1263941493850672K042330ACETAMINOPHEN-SL ASSAYLDP2005-01-07
1263941051462613K042329SALICYLATE-SL ASSAYDKJ2004-12-27
1263941144716153K042243MICROALBUMIN MULTI-CALIBRATOR SETJIX2004-10-04
1263941062048346K033921AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10JIF2004-03-10
1263941337452234K030546CRP (II) CALIBRATORSJIS2003-06-02
1263941737659014K030545CRP-LATEX (II)X2 SEIKEN ASSAY KITDCK2003-06-02
1263941688009267K023739GLUCOSE-SL-C ASSAY, MODEL 257-30CFR2003-01-17
1263941101700592K023330BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30CIG2002-12-11
1263941455261119K021316ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATORLBS2002-07-25
1263941971261788K020816IRON-PC-SL ASSAY MODEL # 151-10, 151-26JIY2002-05-14
1263941466398560K011843GENZYME DIRECT-AMYLASE TEST REAGENTJFJ2001-08-10
1263941489353388K003093ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30CJE2000-11-27
1263941995343535K002694UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30CDQ2000-09-15
1263941270068338K002354CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80KHS2000-09-26
1263941077676233K001286ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10DIC2000-06-20
1263941162035762K000055CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17CGX2000-02-18
1263941066167472
1263941076525122
1263941080745915
1263941089039227
1263941092691105
1263941116697413
1263941123078074
1263941136570388
1263941143358445
1263941148298486
1263941172411911
1263941282777045
1263941291392400
1263941331199362
1263941401061042
1263941402275872
1263941432451489
1263941438746552
1263941484447226
1263941497934481
1263941504306159
1263941514750083
1263941517228654
1263941547651506
1263941584731774
1263941586149930
1263941689736600
1263941702769038
1263941729353085
1263941740119332
1263941765029308
1263941770201627
1263941775697447
1263941778605420
1263941799853781
1263941843886628
1263941848675466
1263941866598796
1263941877258207
1263941882705277
1263941930845305
1263941935887439
1263942002460311
1263942040869065

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CIG62008-12-16
LDP42022-02-18
JIX32004-10-04
JIT22016-12-08
JGJ22011-12-02
DCK22006-04-28
KHS22004-12-27
JIF22004-03-10
JIS22003-06-02
CFR22003-01-17
LBS22002-07-25
JIY22002-05-14
CEK21998-03-02
JMO21996-08-27
CHH21989-12-12
PDJ12018-07-12
JFY12007-06-22
DCF12005-07-05
DKJ12004-12-27
JFJ12001-08-10
CJE12000-11-27
CDQ12000-09-15
DIC12000-06-20
CGX12000-02-18
MRR11999-10-18
CGS11998-03-11
CEO11998-01-30
CKA11997-12-05
CIT11997-11-13
JQB11997-11-04
LBR11997-06-18
CDT11996-08-16
KNK11996-07-23
CHI11990-02-26
CJY11989-12-12
CGA11988-04-18
JJY11988-01-05
CIX11984-09-07

PMN#