Tosoh Aia Inc

FDA Filings

This page includes the latest FDA filings for Tosoh Aia Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9612316
FEI Number3002808328
NameTOSOH AIA, INC.
Owner & OperatorTOSOH BIOSCIENCE
Contact Address6000 Shoreline Ct Suite 101
South San Francisco CA 94080 US
Official Correspondent
  • Ken Hood
  • 1-650-6368228-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2, IWASEKOSHI-MACHI
TOYAMA Toyama, 931-8510 JP
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
Tosoh ST AIA-PACK 25-OH Vitamin D Pretreatment Set2019-06-11
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
Tosoh ST AIA-PACK 20-OH Vitamin D Calibrator Set2019-06-11
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
Tosoh AIA-Pack 25-OH Vitamin D Test2019-06-11
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
Tosoh AIA-Pack 25-OH Vitamin D Control Set2019-06-11
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
Tosoh ST AIA-PACK 25-OH Vitamin D Pretreatment Set2019-06-11
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
Tosoh ST AIA-PACK 20-OH Vitamin D Calibrator Set2019-06-11
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
Tosoh AIA-Pack 25-OH Vitamin D Test2019-06-11
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
Tosoh AIA-Pack 25-OH Vitamin D Control Set2019-06-11
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK Osteocalcin2017-09-13
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK Osteocalcin Control Set2017-09-13
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK Osteocalcin Calibrator Set2017-09-13
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK Troponin 3rd Generation2017-06-13
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK Troponin 3rd Generation Sample Diluting Solution2017-06-13
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK Thyroglobulin2017-06-12
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK Thyroglobulin Sample Diluting Solution2017-06-12
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK Thyroglobulin Calibrator Set2017-06-12
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK D-Dimer2017-06-12
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK D-Dimer Sample Diluting Solution2017-06-12
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK D-Dimer Control Set2017-06-12
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK D-Dimer Calibrator Set2017-06-12
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK Thyroglobulin Control Set2017-06-12
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK PSA II2017-04-19
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK PSA II Sample Diluting Solution2017-04-19
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK PSA II Calibrator Set2017-04-19
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK Free PSA2017-04-19
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK Free PSA Sample Diluting Solution2017-04-19
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK Free PSA Calibrator Set2017-04-19
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK CTNI3 Calibrator2017-04-19
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK BHCG II2017-04-19
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK BHCG II Sample Diluting Solution2017-04-19
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK BHCG II Calibrator Set2017-04-19
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK Sample Diluting Solution2017-04-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK CA 15-32017-04-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK CA 15-3 Calibrator Set2017-04-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK HBeAg2017-04-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK HBeAg Calibrator Set2017-04-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK HBeAb2017-04-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK Infectious Ab Control Set2017-04-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK HBeAg Sample Diluting Solution2017-04-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK HBcAb2017-04-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK HBcAb Sample Diluting Solution2017-04-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK HBcAb Calibrator Set2017-04-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK HBV Antigen Control Set2017-04-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK HBsAg2017-04-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK HBsAg Calibrator2017-04-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK HBsAb2017-04-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK HBsAb Calibrator2017-04-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK HBsAg Sample Diluting Solution2017-04-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK HBsAb Sample Diluting Solution2017-04-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK BNP2017-01-30
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK BNP Sample Diluting Solution2017-01-30
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK BNP Calibrator Set2017-01-30
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK BNP Control Set2017-01-30
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK Progesterone III Calibrator Set2016-07-08
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK hsE2 Calibrator Set2016-02-29
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK SHBG2015-07-07
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK SHBG Calibrator2015-07-07
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK SHBG2015-07-07
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK SHBG Calibrator2015-07-07
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK C-Peptide Control Set2014-12-17
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK Progesterone II Calibrator Set2014-12-05
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK Progesterone II2014-12-05
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK C-Peptide II2014-08-11
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK 25-OH Vitamin D2013-02-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK 25-OH Vitamin D Calibrator Set2013-02-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK 25-OH Vitamin D Control Set2013-02-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK 25-OH Vitamin D2013-02-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK 25-OH Vitamin D Calibrator Set2013-02-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK 25-OH Vitamin D Control Set2013-02-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK 25-OH Vitamin D2013-02-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK 25-OH Vitamin D Calibrator Set2013-02-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK 25-OH Vitamin D Control Set2013-02-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST-DHEA-S Calibrator2012-12-13
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK Homocysteine2012-06-19
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK Homocysteine2012-06-19
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK Homocysteine2012-06-19
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST-AIA-ACTH2012-02-01
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST-AIA-ACTH2012-02-01
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST-AIA-ACTH2012-02-01
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA PACK Cystatin C2010-09-16
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA PACK Cystatin C2010-09-16
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
Tosoh ST AIA-PACK HbA1c2010-09-03
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
Tosoh ST AIA-PACK HbA1c2010-09-03
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
Tosoh ST AIA-PACK HbA1c2010-09-03
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK HCG2010-03-18
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK RBC Folate2009-10-15
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK PA Calibration Ver.2009-06-03
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA PACK FSH Calibration Ver.2009-06-03
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK AFP Calibration Ver.2009-06-03
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA PACK PRL Calibration Ver.2009-06-03
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK BHCG Calibration Ver.2009-06-03
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK TgAb2009-05-29
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK CEA Cal Verification Set2009-05-29
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK PAP2009-05-29
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK PAP2009-05-29
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK CA 19-92009-05-29
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK CA 19-92009-05-29
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK FT32009-05-27
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK FT32009-05-27
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
Tosoh AIA-Pack TT32009-05-26
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK PAP Calibration Ver2009-05-26
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK FER2009-05-22
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK FER2009-05-22
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK T42009-05-11
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK T42009-05-11
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK FER CALIBRATION VER2009-05-08
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA2009-03-31
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK PSA2008-12-03
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK PSA2008-12-03
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK PSA2008-12-03
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK PSA2008-12-03
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST-AIA-PACK Intact PTH2007-12-11
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST-AIA-PACK Intact PTH2007-12-11
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST-AIA-PACK Intact PTH2007-12-11
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK B122005-11-15
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK B12 CALIBRATOR SET,AIA-PACK B12 SAMPLE DILUTING SOLUTION,AIA-PACK B12 PRETREATMENT SET2005-11-15
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK CTNI2 ND-GEN2005-11-15
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK CTNI2 ND-GEN2005-11-15
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK FOLATE2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK TPOAB2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK TPOAB Calibrator,AIA-PACK TPOAB Control Set,AIA-PACK TPOAB/TgAb Sample diluting solution2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK MYOGLOBIN2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK MYOGLOBIN CALIBRATOR,ST AIA-PACK MYOGLOBIN SAMPLE DILUTING SOLUTION2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK IGEII2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK IGE II CALIBRATOR SET, AIA-PACK IGE II SAMPLE DILUTING SOLUTION2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK TSH2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK TSH3G2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK TSH 3rd Gen,AIA-PACK TSH 3rd Gen Calibrator Set,AIA-PACK TSH 3rd Gen Sample Diluting Solution2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK TSH2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK TSH3G2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK TSH 3rd Gen,AIA-PACK TSH 3rd Gen Calibrator Set,AIA-PACK TSH 3rd Gen Sample Diluting Solution2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK CORT2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK CORT2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK CORT Calibrator Set, AIA-PACK CORT Sample Diluting Solution2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK FT42005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK FT4 Calibrator Set2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK FT42005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK FT42005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK FT4 Calibrator Set2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK CKMB2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK CKMB2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK CKMB Calibrator Set, AIA-PACK CKMB Sample Diluting Solution2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK BMG2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK BMG2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK BHCG2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK BHCG2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK BHCG Calibrator Set, AIA-PACK BHCG Sample dilutiing solution2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK AFP2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK AFP CALIBRATOR SET,ST AIA-PACK AFP SAMPLE DILUTING SOLUTION2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK AFP2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK AFP CALIBRATOR SET,ST AIA-PACK AFP SAMPLE DILUTING SOLUTION2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK CEA2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK CEA2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK CA 1252005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK TESTOSTERONE CALIBRATOR SET, ST AIA-PACK TESTOSTERONE SAMPLE DILUTING SOLUTION2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK TESTOSETERONE2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK 27.292005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK 27.292005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK 27.29 Calibrator Set,AIA-PACK 27.29 Sample diluting solution2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST-AIA-DHEA-S2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK DHEA-S Calibrator Set,ST AIA-PACK DHEA-S Sample Diluting Solution2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK FSH2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK PRL2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
AIA-PACK PRL Calibrator Set,AIA-PACK PRL Sample Diluting Solution2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK LHII2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK LH II CALIBRATOR,ST AIA-PACK LH II SAMPLE DILUTING SOLUTION2005-11-14
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK T-U2005-05-20
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK IRI2005-05-20
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK HGH2005-05-20
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK C-PEPTIDE1997-05-07
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK C-PEPTIDE II1997-05-07
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK TT31994-09-02
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK hsE2 Sample Diluting Solution1994-04-20
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK ESTRADIOL1994-04-20
TOSOH AIA, INC. [TOSOH BIOSCIENCE]
ST AIA-PACK PROG1994-04-04

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