This page includes the latest FDA filings for Fujirebio Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Registration Number | 3002895169 |
FEI Number | 3002895169 |
Name | Fujirebio Inc. |
Owner & Operator | Fujirebio Diagnostics, Inc. |
Contact Address | 201 Great Valley Parkway Malvern PA 19355 US |
Official Correspondent |
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US Agent |
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Registration Status | 1 |
Initial Importer | N |
Registration Expiration | 2020-04-25 |
Registration Address | 1-3-14 Tanashioda, Chuo-ku Sagamihara Kanagawa, 252-0245 JP |
Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
---|---|---|
FUJIREBIO INC. | Lumipulse BRAHMS PCT Controls | 2023-05-04 |
FUJIREBIO INC. | Lumipulse G BRAHMS PCT Calibrator Set | 2023-05-04 |
FUJIREBIO INC. | Lumipulse B-Amyloid Controls | 2022-11-08 |
FUJIREBIO INC. | Lumipulse G B-Amyloid 1-40 Calibrator Set | 2022-11-08 |
FUJIREBIO INC. | Lumipulse G B-Amyloid 1-42 Immunoreaction Calibrator Set | 2022-11-08 |
FUJIREBIO INC. | Lumipulse G SARS-CoV-2 Ag Immunoreaction Cartridges | 2022-03-22 |
FUJIREBIO INC. | Lumipulse SARS-CoV-2 Ag Controls | 2022-03-22 |
FUJIREBIO INC. | Lumipulse G SARS-CoV-2 Ag Calibrator Set | 2022-03-22 |
FUJIREBIO INC. | Lumipulse G B-Amyloid 1-40 Immunoreaction Cartridges | 2022-03-22 |
FUJIREBIO INC. | Lumipulse B-Amyloid Controls | 2022-03-22 |
FUJIREBIO INC. | Lumipulse G B-Amyloid 1-40 Calibrator Set | 2022-03-22 |
FUJIREBIO INC. | Lumipulse G B-Amyloid 1-42 Immunoreaction Cartridges | 2022-03-22 |
FUJIREBIO INC. | Lumipulse G B-Amyloid 1-42 Immunoreaction Calibrator Set | 2022-03-22 |
FUJIREBIO INC. | Lumipulse G Wash Solution | 2020-02-07 |
FUJIREBIO INC. | Soda Lime for LUMIPULSE System | 2020-01-20 |
FUJIREBIO INC. | Lumipulse BRAHMS PCT Controls | 2020-01-09 |
FUJIREBIO INC. | Lumipulse PTH Controls | 2020-01-09 |
FUJIREBIO INC. | LUMIPULSE G1200 | 2020-01-06 |
FUJIREBIO INC. | Lumipulse G Dilution Cartridges | 2020-01-06 |
FUJIREBIO INC. | Lumipulse G Whole PTH Calibrators | 2019-12-26 |
FUJIREBIO INC. | Lumipulse G whole PTH Immunoreaction Cartridges | 2019-12-26 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G whole PTH Immunoreaction Cartridges | 2019-12-18 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G whole PTH Calibrators | 2019-12-18 |
FUJIREBIO INC. | Lumipulse G Testosterone Immunoreaction Cartridges | 2019-11-12 |
FUJIREBIO INC. | Lumipulse G BHCG Immunoreaction Cartridges | 2019-11-12 |
FUJIREBIO INC. | Lumipulse G Mesothelin Immunoreaction Cartridges | 2019-11-12 |
FUJIREBIO INC. | Lumipulse G CA 19-9-N Immunoreaction Cartridges | 2019-11-12 |
FUJIREBIO INC. | Lumipulse G CA 15-3 Immunoreaction Cartridges | 2019-11-12 |
FUJIREBIO INC. | Lumipulse G Specimen Diluent 6 | 2019-11-12 |
FUJIREBIO INC. | Lumipulse G Mesothelin Calibrator | 2019-11-12 |
FUJIREBIO INC. | Lumipulse G BHCG Calibrators | 2019-11-12 |
FUJIREBIO INC. | Lumipulse G Specimen Diluent 2 | 2019-11-12 |
FUJIREBIO INC. | Lumipulse G Specimen Diluent 3 | 2019-11-12 |
FUJIREBIO INC. | Lumipulse G Testosterone Calibrators | 2019-11-12 |
FUJIREBIO INC. | Lumipulse G CA 19-9-N Calibrators | 2019-11-12 |
FUJIREBIO INC. | Lumipulse G CA 15-3 Calibrators | 2019-11-12 |
FUJIREBIO INC. | Lumipulse G Substrate Solution | 2019-03-11 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse PTH Controls | 2018-12-05 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse BRAHMS PCT Controls | 2018-12-05 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Alinity i HE4 Controls | 2018-12-05 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Alinity i CA 19-9XR Controls | 2018-12-05 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Alinity i CA 15-3 Controls | 2018-12-05 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Alinity i CA 125II Controls | 2018-12-05 |
FUJIREBIO INC. | Lumipulse G Progesterone-N Immunoreaction Cartridg | 2018-10-19 |
FUJIREBIO INC. | Lumipulse G E2-III Immunoreaction Cartridges | 2018-10-19 |
FUJIREBIO INC. | Lumipulse G E2-III Calibrators | 2018-10-19 |
FUJIREBIO INC. | Lumipulse G Progesterone-N Calibrators | 2018-10-19 |
FUJIREBIO INC. | Lumipulse G LH Immunoreaction Cartridges | 2018-07-06 |
FUJIREBIO INC. | Lumipulse G FSH-N Immunoreaction Cartridges | 2018-07-06 |
FUJIREBIO INC. | Lumipulse G Prolactin Immunoreaction Cartridges | 2018-07-06 |
FUJIREBIO INC. | Lumipulse G 25-OH Vitamin D Immunoreaction Cartrid | 2018-07-06 |
FUJIREBIO INC. | Lumipulse G BRAHMS PCT Immunoreaction Cartridges | 2018-07-06 |
FUJIREBIO INC. | Lumipulse G TP-N Immunoreaction Cartridges Set | 2018-07-06 |
FUJIREBIO INC. | Lumipulse G CA125II Immunoreaction Cartridges | 2018-07-06 |
FUJIREBIO INC. | Lumipulse G HE4 Calibrators | 2018-07-06 |
FUJIREBIO INC. | Lumipulse G HE4 Immunoreaction Cartridges | 2018-07-06 |
FUJIREBIO INC. | Lumipulse G BRAHMS PCT Calibrator Set | 2018-07-06 |
FUJIREBIO INC. | Lumipulse G 25-OH Vitamin D Calibrators | 2018-07-06 |
FUJIREBIO INC. | Lumipulse G Specimen Diluent 1 | 2018-07-06 |
FUJIREBIO INC. | Lumipulse G FSH-N Calibrators | 2018-07-06 |
FUJIREBIO INC. | Lumipulse G LH Calibrators | 2018-07-06 |
FUJIREBIO INC. | Lumipulse G CA125II Calibrators | 2018-07-06 |
FUJIREBIO INC. | Beckman Coulter PK CMV-PA System PA2300 | 2018-07-06 |
FUJIREBIO INC. | Beckman Coulter PK TP System PH3000 | 2018-07-06 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G BRAHMS PCT Immunoreaction Cartridges | 2018-04-02 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G BRAHMS PCT Calibrator Set | 2018-04-02 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G BRAHMS PCT Calculator Tool | 2018-04-02 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G BRAHMS PCT Immunoreaction Cartridges | 2018-04-02 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G BRAHMS PCT Calibrator Set | 2018-04-02 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G BRAHMS PCT Calculator Tool | 2018-04-02 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G BRAHMS PCT Immunoreaction Cartridges | 2018-04-02 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G BRAHMS PCT Calibrator Set | 2018-04-02 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G BRAHMS PCT Calculator Tool | 2018-04-02 |
FUJIREBIO INC. | Lumipulse G TSH-III Immunoreaction Cartridges | 2018-03-29 |
FUJIREBIO INC. | Lumipulse G TSH-III Calibrators | 2018-03-29 |
FUJIREBIO INC. | Lumipulse G Prolactin Calibrators | 2018-03-29 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G TSH-III Immunoreaction Cartridges and Calibrators | 2017-10-31 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G Prolactin Immunoreaction Cartridges | 2017-10-16 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G Prolactin Calibrators | 2017-10-16 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G LH Immunoreaction Cartridges | 2017-08-31 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G LH Calibrators | 2017-08-31 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G FSH-N Immunoreaction Cartridges | 2017-07-26 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G FSH-N Calibrators | 2017-07-26 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G TP-N Immunreaction Cartridges Set | 2016-07-29 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G 25-OH Vitamin D | 2016-07-14 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G 25-OH Vitamin D Calibrators | 2016-07-14 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G 25-OH Vitamin D | 2016-07-14 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G 25-OH Vitamin D Calibrators | 2016-07-14 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G HE4 Immunoreaction Cartridges | 2016-04-19 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G HE4 Calibrators | 2016-04-19 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G HE4 Immunoreaction Cartridges | 2016-04-19 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G HE4 Calibrators | 2016-04-19 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G CA125II Immunoreaction Cartridges | 2016-04-19 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G CA125II Calibrators | 2016-04-19 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | LUMIPULSE G1200 System | 2016-04-19 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G CA125II Immunoreaction Cartridges | 2016-04-19 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G CA125II Calibrators | 2016-04-19 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | LUMIPULSE G1200 System | 2016-04-19 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G CA125II Immunoreaction Cartridges | 2016-04-19 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | Lumipulse G CA125II Calibrators | 2016-04-19 |
Fujirebio Inc. [Fujirebio Diagnostics, Inc.] | LUMIPULSE G1200 System | 2016-04-19 |
Fujirebio, Inc. | Quality Control Kits For Blood Banking Reagents | 1995-11-29 |
NCAGE Code | SJE25 | FUJIREBIO INC. |
CAGE Code | SJE25 | FUJIREBIO INC. |
Import ID | Shipment | Cargo Description | Quantity |
---|---|---|---|
2020062521269 | Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey | INSTRUMENT & APPLIANCE FOR MEDICAL SURGICAL | 6 CAS |
2019041918088 | Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey | INSTRUMENT & APPLIANCE FOR MEDICAL SURGICAL | 6 CAS |
201804049941 | Pusan,South Korea -> Houston, Texas | PLASTIC BOXES, CASES AND CRATES | 50 CTN |