This page includes the latest FDA filings for Tosoh Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3008787992 |
| FEI Number | 3008787992 |
| Name | Michael Van de Woude |
| Owner & Operator | TOSOH Corporation |
| Contact Address | Shiba-koen Frist Building, 3-8-2, Shiba Minato-ku JP-13 Tokyo 105-0014 JP |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 US |
| Establishment Type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
Device Company | Device | Date |
|---|---|---|
| TOSOH CORPORATION | AIA-PACK Homocysteine Control Set | 2024-04-01 |
| TOSOH CORPORATION | AIA-PACK bHCG Calibration Verification Test Set | 2024-04-01 |
| TOSOH CORPORATION | AIA-PACK PAP CALIBRATION VERIFICATION TEST SET | 2024-04-01 |
| TOSOH CORPORATION | AIA-PACK FER Calibration Verification Test Set | 2024-04-01 |
| TOSOH CORPORATION | AIA-PACK CEA Calibration Verification Test Set | 2024-04-01 |
| TOSOH CORPORATION | AIA-PACK AFP Calibration Verification Test Set | 2024-04-01 |
| TOSOH CORPORATION | ST AIA-PACK SHBG | 2024-02-14 |
| TOSOH CORPORATION | ST AIA-PACK C-Peptide II | 2024-02-14 |
| TOSOH CORPORATION | ST AIA-PACK hsE2 | 2024-02-14 |
| TOSOH CORPORATION | ST AIA-PACK DHEA-S | 2024-02-14 |
| TOSOH CORPORATION | ST AIA-PACK PRL | 2024-02-14 |
| TOSOH CORPORATION | ST AIA-PACK LH II | 2024-02-14 |
| TOSOH CORPORATION | ST AIA-PACK HGH | 2024-02-14 |
| TOSOH CORPORATION | ST AIA-PACK IRI | 2024-02-14 |
| TOSOH CORPORATION | ST AIA-PACK FSH | 2024-02-14 |
| TOSOH CORPORATION | ST AIA-PACK E2 | 2024-02-14 |
| TOSOH CORPORATION | ST AIA-PACK TT3 | 2024-02-14 |
| TOSOH CORPORATION | ST AIA-PACK FT3 | 2024-02-14 |
| TOSOH CORPORATION | AIA-PACK SHBG CONTROL SET | 2024-02-14 |
| TOSOH CORPORATION | ST AIA-PACK SHBG SAMPLE DILUTING SOLUTION | 2024-02-14 |
| TOSOH CORPORATION | ST AIA-PACK SHBG CALIBRATOR SET | 2024-02-14 |
| TOSOH CORPORATION | AIA-PACK C-Peptide II Sample Diluting Solution | 2024-02-14 |
| TOSOH CORPORATION | AIA-PACK IRI CONTROL SET | 2024-02-14 |
| TOSOH CORPORATION | ST AIA-PACK hsE2 SAMPLE DILUTING SOLUTION | 2024-02-14 |
| TOSOH CORPORATION | ST AIA-PACK DHEA-S Sample Diluting Solution | 2024-02-14 |
| TOSOH CORPORATION | AIA-PACK PRL CALIBRATION VERIFICATION TEST SET | 2024-02-14 |
| TOSOH CORPORATION | AIA-PACK FSH Calibration Verification Test Set | 2024-02-14 |
| TOSOH CORPORATION | AIA-PACK C-Peptide Control Set | 2024-02-14 |
| TOSOH CORPORATION | AIA-PACK PRL CALIBRATOR SET | 2024-02-14 |
| TOSOH CORPORATION | AIA-PACK PRL SAMPLE DILUTING SOLUTION | 2024-02-14 |
| TOSOH CORPORATION | AIA-PACK LH II SAMPLE DILUTING SOLUTION | 2024-02-14 |
| TOSOH CORPORATION | ST AIA-PACK LH II CALIBRATOR SET | 2024-02-14 |
| TOSOH CORPORATION | AIA-PACK IRI CALIBRATOR SET | 2024-02-14 |
| TOSOH CORPORATION | AIA-PACK IRI SAMPLE DILUTING SOLUTION | 2024-02-14 |
| TOSOH CORPORATION | AIA-PACK FSH Calibrator Set | 2024-02-14 |
| TOSOH CORPORATION | AIA-PACK FSH Sample Diluting Solution | 2024-02-14 |
| TOSOH CORPORATION | ST AIA-PACK E2 CALIBRATOR SET | 2024-02-14 |
| TOSOH CORPORATION | AIA-PACK E2 Sample Diluting Solution | 2024-02-14 |
| TOSOH CORPORATION | AIA-PACK TT3 CALIBRATOR SET | 2024-02-14 |
| TOSOH CORPORATION | AIA-PACK TT3 SAMPLE DILUTING SOLUTION | 2024-02-14 |
| TOSOH CORPORATION | AIA-PACK FT3 Calibrator Set | 2024-02-14 |
| TOSOH CORPORATION | ST AIA-PACK hsE2 CALIBRATOR SET | 2024-02-14 |
| TOSOH CORPORATION | ST AIA-PACK T-U | 2024-02-05 |
| TOSOH CORPORATION | AIA-PACK T-U CALIBRATOR SET | 2024-02-05 |
| TOSOH CORPORATION | Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL300 | 2023-06-22 |
| TOSOH CORPORATION | Auto-Prep Unit for AIA-CL1200 | 2023-06-22 |
| TOSOH CORPORATION | Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL1200 | 2023-06-22 |
| TOSOH CORPORATION | Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL1200 | 2023-06-22 |
| TOSOH CORPORATION | Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL2400 | 2023-06-22 |
| TOSOH CORPORATION | Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL2400 | 2023-06-22 |
| TOSOH CORPORATION | AIA-PACK DILUENT CONCENTRATE | 2023-06-02 |
| TOSOH CORPORATION | AIA-PACK WASH CONCENTRATE | 2023-06-02 |
| TOSOH CORPORATION | AIA-PACK SUBSTRATE SET II | 2022-12-08 |
| TOSOH CORPORATION | AIA-PACK HGH Calibrator Set | 2022-09-16 |
| TOSOH CORPORATION | AIA-PACK HGH Sample Diluting Solution | 2022-09-16 |
| TOSOH CORPORATION | AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-2000 LA N/A | 2022-09-16 |
| TOSOH CORPORATION | AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-2000 ST | 2022-09-16 |
| TOSOH CORPORATION | 19tray Sorter | 2022-09-16 |
| TOSOH CORPORATION | 9tray Sorter | 2022-09-16 |
| TOSOH CORPORATION | AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-900 | 2022-09-16 |
| TOSOH CORPORATION | AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360 | 2022-09-16 |
| TOSOH CORPORATION | AIA-PACK BNP CONTROL SET 0025428 | 2021-01-11 |
| TOSOH CORPORATION | ST AIA-PACK BNP CALIBRATOR SET 0025328 | 2021-01-11 |
| TOSOH CORPORATION | ST AIA-PACK BNP 0025228 | 2021-01-11 |
| TOSOH CORPORATION | ST AIA-PACK PA | 2020-02-06 |
| TOSOH CORPORATION | AIA-PACK PA SAMPLE DILUTING SOLUTION | 2020-02-06 |
| TOSOH CORPORATION | AIA-PACK PA CALBRATOR SET | 2020-02-06 |
| TOSOH CORPORATION | AIA-PACK PA CALIBRATION VERIFICATION TEST SET | 2020-02-06 |
| TOSOH CORPORATION | ST AIA-PACK Intact PTH | 2019-12-23 |
| TOSOH CORPORATION | ST AIA-PACK Intact PTH CALIBRATOR SET | 2019-12-23 |
| TOSOH CORPORATION | ST AIA-PACK Intact PTH SAMPLE DILUTING SOLUTION | 2019-12-23 |
| TOSOH CORPORATION | AIA-PACK Intact PTH CONTROL SET | 2019-12-23 |
| TOSOH CORPORATION | ST AIA-PACK PROG II | 2019-07-22 |
| TOSOH CORPORATION | ST AIA-PACK PROG III | 2019-07-19 |
| TOSOH CORPORATION | ST AIA-PACK PROG III SAMPLE DILUTING SOLUTION | 2019-07-19 |
| TOSOH CORPORATION | ST AIA-PACK PROG III CALIBRATOR SET | 2019-07-19 |
| TOSOH CORPORATION | ST-AIA-PACK PROG II SAMPLE DILUTING SOLUTION | 2019-07-19 |
| TOSOH CORPORATION | ST AIA-PACK PROG II CALIBRATOR SET | 2019-07-19 |
| TOSOH CORPORATION | ST AIA-PACK CA 19-9 | 2019-01-08 |
| TOSOH CORPORATION | ST AIA-PACK BMG | 2018-05-31 |
| TOSOH CORPORATION | ST AIA-PACK HCG | 2018-03-29 |
| TOSOH CORPORATION | ST AIA-PACK T4 | 2018-03-29 |
| TOSOH CORPORATION | ST AIA-PACK CEA | 2018-03-29 |
| TOSOH CORPORATION | ST AIA-PACK CORT | 2018-03-29 |
| TOSOH CORPORATION | ST AIA-PACK CK-MB | 2018-03-29 |
| TOSOH CORPORATION | ST AIA-PACK PAP | 2018-03-29 |
| TOSOH CORPORATION | AIA-PACK TgAb | 2018-03-29 |
| TOSOH CORPORATION | ST AIA-PACK FER | 2018-03-29 |
| TOSOH CORPORATION | ST AIA-PACK TSH | 2018-03-29 |
| TOSOH CORPORATION | AIA-PACK TPOAb | 2018-03-29 |
| TOSOH CORPORATION | ST AIA-PACK FT4 | 2018-03-29 |
| TOSOH CORPORATION | ST AIA-PACK AFP | 2018-03-29 |
| TOSOH CORPORATION | ST AIA-PACK CA 125 | 2018-03-29 |
| TOSOH CORPORATION | ST AIA-PACK 27.29 | 2018-03-29 |
| TOSOH CORPORATION | ST AIA-PACK IgEII | 2018-03-29 |
| TOSOH CORPORATION | ST AIA-PACK cTnI 2 | 2018-03-29 |
| TOSOH CORPORATION | ST AIA-PACK Myoglobin | 2018-03-29 |
| TOSOH CORPORATION | ST AIA-PACK βHCG | 2018-03-29 |
| TOSOH CORPORATION | AIA-PACK TSH 3rd-Gen | 2018-03-29 |
| TOSOH CORPORATION | ST AIA-PACK Testosterone | 2018-03-29 |
TOSOH CORP. | ST AIA-PACK CA 19-9 | 2002-12-23 |
TOSOH CORP. | AIA-PACK CA 19-9 | 2002-12-23 |
TOSOH CORP. | AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM | 1992-07-21 |
TOSOH CORP. | AIA-PACK T-U | 1991-09-30 |
TOSOH CORP. | AIA-PACK CK-MB | 1991-09-27 |
TOSOH CORP. | AIA-PACK FT4 | 1991-09-10 |
TOSOH CORP. | AIA-PACK IRI | 1990-09-07 |
TOSOH CORP. | MPR-4A - MICRO-PLATE READER | 1990-05-10 |
TOSOH CORP. | AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM | 1990-05-02 |
TOSOH CORP. | TOSOH AIA-PACK T3 | 1990-03-09 |
TOSOH CORP. | AIA-PACK T4 | 1990-03-09 |
| NCAGE Code | SV828 | TOSOH CORPORATION |
| NCAGE Code | SP990 | TOSOH CORP. |
| CAGE Code | SV828 | TOSOH CORPORATION |
| CAGE Code | SP990 | TOSOH CORP. |
| SEC | 0001446435 | Tosoh Corp of JAPAN |
| SEC | 1446435 | Tosoh Corp of JAPAN |
| SEC | 0001520251 | TOSOH CORPORATION/ADR |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2019051731185 | Pusan,South Korea -> Seattle, Washington | DIETHYLENETRIAMINE UN2079, CLASS 8, PG II HTS NO.2921.29 .0030 P.O. NO. : 0000008493 EMER | 1 TNK |
| 201905172037 | Shanghai ,China (Mainland) -> Charleston, South Carolina | NITROGEN AMINE FUNCTION COMPOUND HS CODE 292129 | 80 DRM |
| 2019051720778 | Nagoya Ko ,Japan -> Los Angeles, California | CHEMICAL PREPARATION MIXTURE OF INORGANIC COMPOUNDS(ZEOLITES) HTS NO.3824.99 | 180 DRM |
| 2019051731143 | Pusan,South Korea -> Seattle, Washington | DIETHYLENETRIAMINE UN2079, CLASS 8, PG II HTS NO.2921.29 .0030 P.O. NO. : 0000008492 EMER | 1 TNK |
| 2019051616204 | Pusan,South Korea -> Jacksonville, Florida | POLYAMINES, LIQUID,CORROSIVE,N O S | 1 TK |
| 2019051616206 | Pusan,South Korea -> Jacksonville, Florida | POLYETHYLENE POLYAMINES | 1 TK |
| 2019051616201 | Pusan,South Korea -> Jacksonville, Florida | POLYAMINES | 1 TK |
| 2019051616207 | Pusan,South Korea -> Jacksonville, Florida | POLYAMINES | 1 TK |