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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
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
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
1263851799358242K983399GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAYMHI1999-01-11
1263621799358242K983399GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAYMHI1999-01-11
2846181799358242K983399GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAYMHI1999-01-11
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
1263851573203556K974159OSOM HCG-URINE TEST MODEL 101JHI1997-12-24
1263621573203556K974159OSOM HCG-URINE TEST MODEL 101JHI1997-12-24
2846181573203556K974159OSOM HCG-URINE TEST MODEL 101JHI1997-12-24
1263851644442584K972231OSOM MONO TEST 143KTN1997-08-26
1263621644442584K972231OSOM MONO TEST 143KTN1997-08-26
2846181644442584K972231OSOM MONO TEST 143KTN1997-08-26
2846181638238152K961423OSOM STREP A TESTGTZ1996-10-11
1263621638238152K961423OSOM STREP A TESTGTZ1996-10-11
1263851638238152K961423OSOM STREP A TESTGTZ1996-10-11
1263851939227014K955141OSOM HCG COMBO TESTJJX1995-12-06
1263621939227014K955141OSOM 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
1263851264461552K240280Nano-Check™ RSV TestGQG2024-07-30
1263851711991991K231187Nano-Check™ COVID-19 Antigen TestQVF2024-01-23
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
1263851889294839K171641Accula Flu A/Flu B TestOZE2018-02-06
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
1263621206751286K050755MODIFICATION TO BVBLUEMXB2005-04-06
1263851206751286K050755MODIFICATION TO BVBLUEMXB2005-04-06
1263851400555140K043385OSOM HCG COMBO TESTJHI2005-04-12
1263621400555140K043385OSOM HCG COMBO TESTJHI2005-04-12
2846181400555140K043385OSOM HCG COMBO TESTJHI2005-04-12
1263851162123604K033864GENZYME OSOM TRICHOMONAS RAPID TESTJWZ2004-04-02
1263621162123604K033864GENZYME OSOM TRICHOMONAS RAPID TESTJWZ2004-04-02
2846181162123604K033864GENZYME OSOM TRICHOMONAS RAPID TESTJWZ2004-04-02
1263621954786495K022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25JIR2002-08-23
1263621612248552
1263621622029879
1263851060695686
1263851304453362
1263851457110201
1263851469823464
1263851482452759
1263851612248552
1263851622029879
1263851628426461
2846181628426461
1263851652806948
1263851735002463
1263851889325841

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PSZ82020-04-03
JHI82005-04-12
KTN42018-06-22
JWZ32004-04-02
GTY32000-01-18
MHI31999-01-11
GTZ31996-10-11
JJX31995-12-06
MXB22005-04-06
LYR21998-09-22
GQG12024-07-30
QVF12024-01-23
OCC12018-11-23
OZE12018-02-06
LLH12010-12-21
KHE12010-07-01
JIR12002-08-23

PMN#

GUDID#

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