Siemens Healthcare Diagnostics

FDA Filings

This page includes the latest FDA filings for Siemens Healthcare Diagnostics. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
FDA Owner/Operator Registration















FDA Filings

Device
Company
DeviceDate
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Complexed PSA (cPSA) Assay2021-04-27
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Prostate-Specific Antigen (PSA) Assay2021-04-27
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B e Antigen (HBeAg) Assay2021-04-27
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Anti-Hepatitis B core Total (HBcT) Assay2021-04-27
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis C (aHCV) Assay2021-04-27
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B core IgM (aHBcM) Assay2021-04-27
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur HBc Total ReadyPack Reagents, ADVIA Centaur HBc Total Quality Control Materials, Atellica IM Anti-Hepatiti2021-03-11
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur HCV ReadyPack Reagents, Atellica IM Hepatitis C (aHCV), Atellica IM Hepatitis C Quality Control(aHCV QC)2021-03-11
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur HBsAg ReadyPack Reagents/ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, ADVIA Centaur HBsAg Quality2021-03-11
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur Hepatitis B Core Antigen (aHBcM) Assay, Atellica IM Hepatitis B Core Antigen (aHBcM) Assay, Atellica IM He2021-03-11
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur PSA Readypack Reagents2020-10-27
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension Vista FPSA Flex reagent cartridge2020-10-13
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension Vista TPSA Flex reagent cartridge2020-10-13
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur cPSA Readypack Reagents2020-08-25
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur PSA Readypack Reagents2020-08-25
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur HBeAg Readypack Reagents and Quality Control Material2020-08-25
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur HBc Total Readypack Reagents and Quality COntrol Materials2020-08-25
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA CENTAUR HCV ReadyPack Reagents and Quality Control Materials2020-08-25
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur HBsAg/Confirmatory Readypack Reagents, Calibrators and Controls2020-08-25
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur HBc IgM Readypack Reagents and Quality Control Material2020-08-25
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur HCV, and Atellica HCV2020-06-21
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Complexed PSA (cPSA) Assay2020-04-03
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Prostate-Specific Antigen (PSA) Assay2020-04-03
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B e Antigen (HBeAg) Assay2020-04-03
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Anti-Hepatitis B core Total (HBcT) Assay2020-04-03
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis C (aHCV) Assay2020-04-03
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B core IgM (aHBcM) Assay2020-04-03
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur and Atellica IM cPSA2020-03-19
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur and Atellica IM PSA2020-03-19
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur and Atellica IM HBeAg2020-03-19
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur and Atellica IM HBc Total2020-03-19
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur and Atellica IM HCV2020-03-19
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur HBsAg2020-03-19
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur and Atellica IM HBc IgM2020-03-19
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur HBsAg2019-10-25
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur PSA, ADVIA Centaur CP PSA and Atellica IM PSA2019-07-25
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension Vista TPSA Flex reagent cartridge (K6452)2019-06-26
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension Vista TPSA Flex reagent cartridge (K6451)2019-06-26
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension FPSA Flex reagent cartridge2019-06-20
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension TPSA Flex reagent cartridge2019-06-20
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Complexed PSA (cPSA) Assay2019-03-08
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Prostate-Specific Antigen (PSA) Assay2019-03-08
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B e Antigen (HBeAg) Assay2019-03-08
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica Im Anti-Hepatitis B core Total (HBcT) Assay2019-03-08
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis C (aHCV) Assay2019-03-08
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B orfe IgM (aHBcM) Assay2019-03-08
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension Vista FPSA Flex reagent cartridge2018-12-27
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension Vista TPSA Flex reagent cartridge2018-12-27
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Complexed PSA (cPSA)2018-10-25
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Prostate-Specific Antigen (PSA)2018-10-25
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B e Antigen (HBeAg)2018-09-11
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM anti-HBc Total (HBcT)2018-09-11
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Analyzer Hepatitis C (aHCV)2018-09-11
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B core IgM (aHBcM)2018-09-11
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B core IgM (aHBcM) assay; Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC)2018-08-24
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM CPSA Assay2018-08-03
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Prostate-Specific Antigen (PSA)2018-08-03
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B e Antigen (HBeAg)2018-07-12
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Anti-Hepatitis B core Total (HBcT), Atellica IM Anti-Hepatitis B core Total Quality Control (HBcT QC)2018-07-06
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA 2120i, ADVIA 21202017-08-11
SIEMENS HEALTHCARE DIAGNOSTICS
LOCI Total Vitamin D Total Assay, LOCI VITD CAL2017-03-16
Siemens Healthcare Diagnostics
Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)2017-03-09
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator2016-11-17
SIEMENS HEALTHCARE DIAGNOSTICS
Xprecia Stride Coagulation System, Xprecia System PT Controls2016-09-30
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)2015-11-04
Siemens Healthcare Diagnostics
Dimension Vista MMB Assay2015-09-18
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex Reagent Cartridge (MG)2015-06-15
Siemens Healthcare Diagnostics
IMMULITE IGF Control Module, IMMULITE Gastrin Control Module2015-04-13
Siemens Healthcare Diagnostics
IMMULITE 2000 CEA Calibration Verification Material2015-01-23
SIEMENS HEALTHCARE DIAGNOSTICS
CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT2014-11-17

Similar & Related FDA Registered Companies

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092998694Anvers,Belgium -> Norfolk, VirginiaDIAGNOSTICA HS CODES 38220000, 30021500, 39269097, 90279000 .50 PCS
20200929105675Stadersand,Federal Republic of Germany -> New York, New YorkSLAC ON 2 PALLETS . PLASTIC BOTTLES WITH EXTR USIONS-BLOW MOULDING AS PER PROFORMA INVOICE-30 PCS
2020092642934Nhava Sheva,India -> New York/Newark Area, Newark, New JerseyPACKING MATERIAL PACKING MATERIAL INVOICE NO MED/ EXP/DX/037 DT. 06.02.2020 SBILL NO 9618459 DT.13/01/2020 HS CODE 48195090 NET.WT 5472.00 KGS18 PCS
2020092677687Stadersand,Federal Republic of Germany -> New York, New YorkSLAC ON 2 PALLETS . PLASTIC BOTTLES WITH EXTR USIONS-BLOW MOULDING AS PER PROFORMA INVOICE-30 PCS
2020092459655Stadersand,Federal Republic of Germany -> New York, New YorkSLAC ON 2 PALLETS . PLASTIC BOTTLES WITH EXTR USIONS-BLOW MOULDING AS PER PROFORMA INVOICE-30 PCS
2020092382493Stadersand,Federal Republic of Germany -> New York, New YorkSLAC ON 2 PALLETS . PLASTIC BOTTLES WITH EXTR USIONS-BLOW MOULDING AS PER PROFORMA INVOICE-30 PCS
202009222580Le Havre,France -> New York/Newark Area, Newark, New JerseyUN1230 CLASS 3(6.1) GEII1479 BOX
202009222580Le Havre,France -> New York/Newark Area, Newark, New JerseyUN1230 CLASS 3(6.1) GEII1479 BOX
202009222580Le Havre,France -> New York/Newark Area, Newark, New JerseyHARMLESS GOODS DIFF QUICK SOLUTIONS1479 BOX
202009222580Le Havre,France -> New York/Newark Area, Newark, New JerseyUN1230 CLASS 3(6.1) GEII1479 BOX

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.