FDA.report

TOSOH BIOSCIENCE, INC.

Matched from indexed company URL: TOSOH CORPORATION

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30055297993005529799TOSOH BIOSCIENCE, INC.1Y2026-01-013600 Gantz Rd Grove City OH US 43123
29504091000123732TOSOH BIOSCIENCE, INC.1Y2020-04-256000 SHORELINE COURT SUITE 101 SOUTH SAN FRANCISCO CA US 94080

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
04560189210172ST AIA-PACK 27.29 - N/A615-806-4671Isabelle.Lang-Zwosta@tosoh.com
04560189213418ST AIA-PACK PROG II CALIBRATOR SET - N/A615-806-4671Isabelle.Lang-Zwosta@tosoh.com
04560189283923Hemoglobin A1c Control Set - N/A615-806-4671Isabelle.Lang-Zwosta@tosoh.com
04562185400571HbA1c Diluting Solution - N/A615-806-4671Isabelle.Lang-Zwosta@tosoh.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
109851234347852P910065AIA-PACK PSAMTF1993-07-07
109871234347852P910065AIA-PACK PSAMTF1993-07-07
109851736316252K992365AIA-PACK FOLATE ASSAYCGN1999-08-10
109871736316252K992365AIA-PACK FOLATE ASSAYCGN1999-08-10
109851372077778K991252AIA-PACK FT3 ASSAYCDP1999-05-11
109871372077778K991252AIA-PACK FT3 ASSAYCDP1999-05-11
109851418772801K981522AIA-PACK TGAB ASSAYJZO1998-10-08
109871418772801K981522AIA-PACK TGAB ASSAYJZO1998-10-08
109851787011769K981521AIA-PACK TPOAB ASSAYJZO1998-10-08
109871787011769K981521AIA-PACK TPOAB ASSAYJZO1998-10-08
109851169143222K981012AIA-PACK MYOGLOBIN ASSAYDDR1998-05-28
109871169143222K981012AIA-PACK MYOGLOBIN ASSAYDDR1998-05-28
109851304853235K972697AIA-PACK IGE II ASSAYDGC1997-10-03
109871304853235K972697AIA-PACK IGE II ASSAYDGC1997-10-03
109851798506618K972586AIA-PACK TSH 3RD-GEN ASSAYJLW1997-08-29
109871798506618K972586AIA-PACK TSH 3RD-GEN ASSAYJLW1997-08-29
109851351695548K972265A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZERLCP1997-09-25
109871351695548K972265A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZERLCP1997-09-25
109851326343303K971103AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEMKHO1997-06-27
109871326343303K971103AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEMKHO1997-06-27
109851888340823K964348AIA-PACK B12 ASSAYCDD1997-01-13
109871888340823K964348AIA-PACK B12 ASSAYCDD1997-01-13
109851885985954K954591AIA-PACK CORT ASSAYJFT1995-12-15
109871885985954K954591AIA-PACK CORT ASSAYJFT1995-12-15
109851395768694K936229AIA-PACK TT3 ASSAYCDP1994-07-14
109871395768694K936229AIA-PACK TT3 ASSAYCDP1994-07-14
109851759665613K932178AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TESJJX1993-09-21
109871759665613K932178AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TESJJX1993-09-21
109851325823997K924863AIA-PACK FSH CALIBRATION VERIFICATION TEST SETJJX1992-11-16
109871325823997K924863AIA-PACK FSH CALIBRATION VERIFICATION TEST SETJJX1992-11-16
109851615865659K924860AIA-PACK AFP CALIBRATION VERIFICATION TEST SETJJX1993-03-04
109871615865659K924860AIA-PACK AFP CALIBRATION VERIFICATION TEST SETJJX1993-03-04
109851383643045K924858AIA-PACK FER CALIBRATION VERIFICATION TEST SETDBF1992-12-15
109871383643045K924858AIA-PACK FER CALIBRATION VERIFICATION TEST SETDBF1992-12-15
109851043642936K924857AIA-PACK CEA CALIBRATION VERIFICATION TEST SETDHX1993-03-18
109871043642936K924857AIA-PACK CEA CALIBRATION VERIFICATION TEST SETDHX1993-03-18
109851648812849K924856AIA-PACK PRL CALIBRATION VERIFICATION TEST SETJJX1993-01-11
109871648812849K924856AIA-PACK PRL CALIBRATION VERIFICATION TEST SETJJX1993-01-11
109851020275674K924854AIA-PACK PAP CALIBRATION VERIFICATION TEST SETJJX1992-11-16
109871020275674K924854AIA-PACK PAP CALIBRATION VERIFICATION TEST SETJJX1992-11-16
109851867246734K924853AIA-PACK BHCG CALIBRATION VERIFICATION TEST SETJJX1992-12-28
109871867246734K924853AIA-PACK BHCG CALIBRATION VERIFICATION TEST SETJJX1992-12-28
109851285329487K913663AIA-PACK T-UKHQ1991-09-30
109871285329487K913663AIA-PACK T-UKHQ1991-09-30
109851329801099K913493AIA-PACK FT4CEC1991-09-10
109871329801099K913493AIA-PACK FT4CEC1991-09-10
109851280382570K913298AIA-PACK CK-MBJHX1991-09-27
109871280382570K913298AIA-PACK CK-MBJHX1991-09-27
109851472316268K900440AIA-PACK BMGJZG1990-02-26
109871472316268K900440AIA-PACK BMGJZG1990-02-26
109851366343322K896982AIA-PACK T4KLI1990-03-09
109871366343322K896982AIA-PACK T4KLI1990-03-09
109851330558953K870521TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAYJHI1987-04-08
109871330558953K870521TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAYJHI1987-04-08
109851036936848K864945TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAYJFH1987-01-05
109871036936848K864945TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAYJFH1987-01-05
109851632189541K863861TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONAJHI1986-11-21
109871632189541K863861TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONAJHI1986-11-21
109851146493782K863345TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAYDBF1986-10-08
109871146493782K863345TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAYDBF1986-10-08
109851045737055K862674PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEMJZT1986-08-15
109871045737055K862674PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEMJZT1986-08-15
109871513799368K250073Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01PDJ2025-10-03
109871917542134K192380ST AIA-PACK BNPNBC2020-08-24
109851650154738K160113ST AIA-PACK hsE2 Calibrator SetJIT2016-02-17
109871650154738K160113ST AIA-PACK hsE2 Calibrator SetJIT2016-02-17
109851364246182K153417ST AIA-PACK PROG III Calibrator SetJIT2015-12-18
109871364246182K153417ST AIA-PACK PROG III Calibrator SetJIT2015-12-18
109851696956661K150270ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment SetMRG2015-10-26
109871696956661K150270ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment SetMRG2015-10-26
109851996398078K143296AIA-PACK C-Peptide Control SetJJX2014-12-16
109871996398078K143296AIA-PACK C-Peptide Control SetJJX2014-12-16
109851577994464K143144ST AIA-PACK PROG II Calibrator SetJIT2014-12-03
109871577994464K143144ST AIA-PACK PROG II Calibrator SetJIT2014-12-03
109851126446878K143075ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator SetCDZ2015-07-02
109871126446878K143075ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator SetCDZ2015-07-02
109851491418526K140648ST AIA-PACK C-PEPTIDE II CALIBRATOR SETJIT2014-04-10
109871491418526K140648ST AIA-PACK C-PEPTIDE II CALIBRATOR SETJIT2014-04-10
109871621695871K131580AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8PDJ2014-01-23
109851977933050K123131ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AIMRG2013-02-08
109871977933050K123131ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AIMRG2013-02-08
109851025582729K121533ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SETLPS2012-06-15
109871025582729K121533ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SETLPS2012-06-15
109851491114541K111762ST AIA-PACK DHEA-S CALIBRATOR SETJIT2011-08-05
109871491114541K111762ST AIA-PACK DHEA-S CALIBRATOR SETJIT2011-08-05
109851342967439K111335ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321CKG2011-12-01
109871342967439K111335ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321CKG2011-12-01
109852010326540K100304ST AIA PACK HBA1CLCP2010-08-27
109872010326540K100304ST AIA PACK HBA1CLCP2010-08-27
109851682667738K093960ST AIA-PACK CYSTATIN C, MODEL 025217NDY2010-09-14
109871682667738K093960ST AIA-PACK CYSTATIN C, MODEL 025217NDY2010-09-14
109852020179666K091332AIA-PACK RBC FOLATECGN2009-10-02
109872020179666K091332AIA-PACK RBC FOLATECGN2009-10-02
109851240554016K071132G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8LCP2008-09-16
109871240554016K071132G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8LCP2008-09-16
109851297596906K063605ST AIA-PACK INTACT PTH ASSAYCEW2007-06-21
109871297596906K063605ST AIA-PACK INTACT PTH ASSAYCEW2007-06-21
109851199035637K023894ST AIA-PACK AFP ENZYME IMMUNOASSAYLOJ2002-12-17
109871199035637K023894ST AIA-PACK AFP ENZYME IMMUNOASSAYLOJ2002-12-17
109851219427465K023893ST AIA-PACK CEA ENZYME IMMUNOASSAYDHX2002-12-18
109871219427465K023893ST AIA-PACK CEA ENZYME IMMUNOASSAYDHX2002-12-18
109851406847799K023891ST AIA-PACK CA 125 ENZYME IMMUNOASSAYLTK2002-12-06
109871406847799K023891ST AIA-PACK CA 125 ENZYME IMMUNOASSAYLTK2002-12-06
109851198548859K023240ST AIA-PACK CA 19-9NIG2002-12-23
109871198548859K023240ST AIA-PACK CA 19-9NIG2002-12-23
109851293293808K023091ST AIA-PACK TESTOSTERONE ASSAYCDZ2002-12-17
109871293293808K023091ST AIA-PACK TESTOSTERONE ASSAYCDZ2002-12-17
109851184354593K020489G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODEJPD2002-05-14
109871184354593K020489G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODEJPD2002-05-14
109851721375164K012820AIA-PACK CTNI 2ND-GEN ASSAYMMI2001-12-14
109871721375164K012820AIA-PACK CTNI 2ND-GEN ASSAYMMI2001-12-14
109851159851841K011434G7 AUTOMATED HPLC ANALYZERLCP2001-09-18
109871159851841K011434G7 AUTOMATED HPLC ANALYZERLCP2001-09-18
109851944554923K010796AIA-PACK BRCA, ST AIA PACK BRCAMOI2001-08-16
109871944554923K010796AIA-PACK BRCA, ST AIA PACK BRCAMOI2001-08-16
109851120679155
109851188880705

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
JJX142014-12-16
JIT102016-02-17
LCP82010-08-27
MRG42015-10-26
CDZ42015-07-02
CGN42009-10-02
DHX42002-12-18
CDP41999-05-11
JZO41998-10-08
DBF41992-12-15
JHI41987-04-08
PDJ22025-10-03
LPS22012-06-15
CKG22011-12-01
NDY22010-09-14
CEW22007-06-21
NIG22002-12-23
LOJ22002-12-17
LTK22002-12-06
JPD22002-05-14
MMI22001-12-14
MOI22001-08-16
DDR21998-05-28
DGC21997-10-03
JLW21997-08-29
KHO21997-06-27
CDD21997-01-13
JFT21995-12-15
MTF21993-07-07
KHQ21991-09-30
JHX21991-09-27
CEC21991-09-10
KLI21990-03-09
JZG21990-02-26
JFH21987-01-05
JZT21986-08-15
NBC12020-08-24

PMA

PMN

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GUDID

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