FDA.reportPublic FDA data

Sekisui Diagnostics, LLC

Matched from indexed company URL: SEKISUI Diagnostics, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20305381000520007Sekisui Diagnostics, LLC1Y2026-01-016659 Top Gun St SAN DIEGO CA US 92121
80203163002806809Sekisui Diagnostics P.E.I. Inc.1N2026-01-0170 Watts Avenue CHARLOTTETOWN Prince Edward Island CA C1E 2B9
30177724383017772438Sekisui Diagnostics, LLC1N2026-01-016740 Cobra Way San Diego CA US 92121
30087760413008776041SEKISUI DIAGNOSTICS, LLC1N2020-04-25One Wall Street Burlington MA US 01803

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
1263621975482188K992658OSOM ULTRA STREP A TEST, MODEL 147GTY2000-01-18
1263851975482188K992658OSOM ULTRA STREP A TEST, MODEL 147GTY2000-01-18
2846181975482188K992658OSOM ULTRA STREP A TEST, MODEL 147GTY2000-01-18
1263621799358242K983399GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAYMHI1999-01-11
1263851799358242K983399GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAYMHI1999-01-11
2846181799358242K983399GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAYMHI1999-01-11
1263941769703973K981609BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30CIG1998-06-03
1263622010856896K980798BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TESTLYR1998-09-22
1263852010856896K980798BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TESTLYR1998-09-22
1263941436046811K974874BILIRUBIN-SL (TOTAL) ASSAYCIG1998-02-12
1263941010773204K974858PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30CEO1998-01-30
1263621573203556K974159OSOM HCG-URINE TEST MODEL 101JHI1997-12-24
1263851573203556K974159OSOM HCG-URINE TEST MODEL 101JHI1997-12-24
2846181573203556K974159OSOM HCG-URINE TEST MODEL 101JHI1997-12-24
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
1263621644442584K972231OSOM MONO TEST 143KTN1997-08-26
1263851644442584K972231OSOM MONO TEST 143KTN1997-08-26
2846181644442584K972231OSOM MONO TEST 143KTN1997-08-26
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
1263621638238152K961423OSOM STREP A TESTGTZ1996-10-11
1263851638238152K961423OSOM STREP A TESTGTZ1996-10-11
2846181638238152K961423OSOM STREP A TESTGTZ1996-10-11
1263941591565093K961282GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60CFR1996-06-21
1263941161967119K961281TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60CDT1996-08-16
1263621939227014K955141OSOM HCG COMBO TESTJJX1995-12-06
1263851939227014K955141OSOM HCG COMBO TESTJJX1995-12-06
2846181939227014K955141OSOM HCG COMBO TESTJJX1995-12-06
1263851730167690K944426BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINEJHI1994-10-25
2846181730167690K944426BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINEJHI1994-10-25
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
1263851264461552K240280Nano-Check™ RSV TestGQG2024-07-30
1263851711991991K231187Nano-Check™ COVID-19 Antigen TestQVF2024-01-23
1263941730338134K202644AcetaminophenLDP2022-02-18
1263851344644650K192719Osom Ultra Plus Flu A&B Test KitPSZ2020-04-03
2846181344644650K192719Osom Ultra Plus Flu A&B Test KitPSZ2020-04-03
1263851114037267K182001Acucy Influenza A&B Test with the Acucy SystemPSZ2018-12-17
2846181114037267K182001Acucy Influenza A&B Test with the Acucy SystemPSZ2018-12-17
1263851642043925K181443Accula RSV TestOCC2018-11-23
1263852059670834K181436OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid TestKTN2018-06-22
1263941523643843K180835SEKURE Acetaminophen L3K AssayLDP2019-02-08
1263941073160253K173206SEKURE HbA1c AssayPDJ2018-07-12
1263851889294839K171641Accula Flu A/Flu B TestOZE2018-02-06
1263941125152610K163078DC-UIBC-CALJIT2016-12-08
1263941826109877K111915MAGNESIUM ASSAYJGJ2011-12-02
1263621290404733K102242OSOM C. DIFFICILE TOXIN A/B TESTLLH2010-12-21
1263851320405119K100817BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TESTKHE2010-07-01
1263851477974038K092633OSOM INFLUENZA A&B TEST , MODEL PN190PSZ2009-09-25
2846181477974038K092633OSOM INFLUENZA A&B TEST , MODEL PN190PSZ2009-09-25
1263851080449597K083746BIOSIGN FLU A+BPSZ2010-11-10
2846181080449597K083746BIOSIGN FLU A+BPSZ2010-11-10
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
1263621206751286K050755MODIFICATION TO BVBLUEMXB2005-04-06
1263851206751286K050755MODIFICATION TO BVBLUEMXB2005-04-06
1263621400555140K043385OSOM HCG COMBO TESTJHI2005-04-12
1263851400555140K043385OSOM HCG COMBO TESTJHI2005-04-12
2846181400555140K043385OSOM HCG COMBO TESTJHI2005-04-12
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
1263621162123604K033864GENZYME OSOM TRICHOMONAS RAPID TESTJWZ2004-04-02
1263851162123604K033864GENZYME OSOM TRICHOMONAS RAPID TESTJWZ2004-04-02
2846181162123604K033864GENZYME OSOM TRICHOMONAS RAPID TESTJWZ2004-04-02
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
1263621954786495K022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25JIR2002-08-23
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
1263621612248552
1263621622029879
1263851060695686
1263941066167472
1263941076525122
1263941080745915
1263941089039227
1263941092691105
1263941116697413
1263941123078074
1263941136570388
1263941143358445
1263941148298486
1263941172411911

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PSZ82020-04-03
JHI82005-04-12
CIG62008-12-16
LDP42022-02-18
KTN42018-06-22
JIX32004-10-04
JWZ32004-04-02
GTY32000-01-18
MHI31999-01-11
GTZ31996-10-11
JJX31995-12-06
JIT22016-12-08
JGJ22011-12-02
DCK22006-04-28
MXB22005-04-06
KHS22004-12-27
JIF22004-03-10
JIS22003-06-02
CFR22003-01-17
LBS22002-07-25
JIY22002-05-14
LYR21998-09-22
CEK21998-03-02
JMO21996-08-27
CHH21989-12-12
GQG12024-07-30
QVF12024-01-23
OCC12018-11-23
PDJ12018-07-12
OZE12018-02-06
LLH12010-12-21
KHE12010-07-01
JFY12007-06-22
DCF12005-07-05
DKJ12004-12-27
JIR12002-08-23
JFJ12001-08-10
CJE12000-11-27
CDQ12000-09-15
DIC12000-06-20

PMN#

GUDID#

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