Siemens Healthcare Diagnostics Products G M B H

FDA Filings

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

FDA Filings

Device Company	Device	Date
GUDID 00630414240404 Siemens Healthcare Diagnostics Products GmbH	INNOVANCE Anti-Xa OPPU05	2024-12-04
GUDID 00630414240343 Siemens Healthcare Diagnostics Products GmbH	INNOVANCE Apixaban Standards OPPW05	2024-12-04
GUDID 00630414240336 Siemens Healthcare Diagnostics Products GmbH	INNOVANCE Apixaban Controls OPPV05	2024-12-04
GUDID 00842768018800 Siemens Healthcare Diagnostics Products GmbH	BC von Willebrand Reagent 10874080	2024-09-20
GUDID 00842768019685 Siemens Healthcare Diagnostics Products GmbH	LA Control High 10873936	2024-04-08
GUDID 00842768019678 Siemens Healthcare Diagnostics Products GmbH	LA Control Low 10873935	2024-04-08
GUDID 00842768019661 Siemens Healthcare Diagnostics Products GmbH	LA 2 Confirmation Reagent 10873902	2024-04-08
GUDID 00842768019654 Siemens Healthcare Diagnostics Products GmbH	LA 1 Screening Reagent 10873904	2024-04-08
GUDID 00630414640433 Siemens Healthcare Diagnostics Products GmbH	vWF Ag 10873845	2024-04-08
GUDID 00842768019845 Siemens Healthcare Diagnostics Products GmbH	Dade CA System Buffer 10873915	2024-04-02
GUDID 00842768019609 Siemens Healthcare Diagnostics Products GmbH	Dade Innovin 10873934	2024-04-02
GUDID 00842768019593 Siemens Healthcare Diagnostics Products GmbH	Dade Innovin 10873932	2024-04-02
GUDID 00842768019586 Siemens Healthcare Diagnostics Products GmbH	Dade Innovin 10873933	2024-04-02
GUDID 00842768019579 Siemens Healthcare Diagnostics Products GmbH	Dade Actin Activated Cephaloplastin Reagent 10873829	2024-04-02
GUDID 00842768019562 Siemens Healthcare Diagnostics Products GmbH	Dade Actin FS Activated PTT Reagent 10873830	2024-04-02
GUDID 00842768019555 Siemens Healthcare Diagnostics Products GmbH	Dade Actin FSL Activated PTT Reagent 10873832	2024-04-02
GUDID 00842768019548 Siemens Healthcare Diagnostics Products GmbH	Dade Ci-Trol Heparin Control, Low 10873833	2024-04-02
GUDID 00842768019531 Siemens Healthcare Diagnostics Products GmbH	Dade Ci-Trol Heparin Control, High 10873834	2024-04-02
GUDID 00842768019524 Siemens Healthcare Diagnostics Products GmbH	Dade Data-Fi Abnormal Fibrinogen Control 10873836	2024-04-02
GUDID 00842768019517 Siemens Healthcare Diagnostics Products GmbH	Dade Thrombin Reagent 10873837	2024-04-02
GUDID 00842768019500 Siemens Healthcare Diagnostics Products GmbH	Dade Thrombin Reagent 10873838	2024-04-02
GUDID 00842768019494 Siemens Healthcare Diagnostics Products GmbH	Dade Owren's Veronal Buffer 10873839	2024-04-02
GUDID 00842768019487 Siemens Healthcare Diagnostics Products GmbH	Dade Hepzyme 10873841	2024-04-02
GUDID 00842768019470 Siemens Healthcare Diagnostics Products GmbH	Dade Ci-Trol Coagulation Control Level 1 10873842	2024-04-02
GUDID 00842768019463 Siemens Healthcare Diagnostics Products GmbH	Dade Ci-Trol Coagulation Control Level 2 10873843	2024-04-02
GUDID 00842768019456 Siemens Healthcare Diagnostics Products GmbH	Dade Ci-Trol Coagulation Control Level 3 10873844	2024-04-02
GUDID 00842768019265 Siemens Healthcare Diagnostics Products GmbH	INNOVANCE® D-Dimer Sample Diluent 10873905	2024-04-02
GUDID 00842768019074 Siemens Healthcare Diagnostics Products GmbH	Pathromtin SL 10873863	2024-04-02
GUDID 00842768019005 Siemens Healthcare Diagnostics Products GmbH	ProC Control Plasma 10873865	2024-04-02
GUDID 00842768018916 Siemens Healthcare Diagnostics Products GmbH	Calcium Chloride Solution 10873872	2024-04-02
GUDID 00842768018893 Siemens Healthcare Diagnostics Products GmbH	Standard Human Plasma 10873907	2024-04-02
GUDID 00842768018879 Siemens Healthcare Diagnostics Products GmbH	Coagulation Factor XI Deficient Plasma 10873883	2024-04-02
GUDID 00842768018862 Siemens Healthcare Diagnostics Products GmbH	Coagulation Factor XII Deficient Plasma 10873877	2024-04-02
GUDID 00842768018855 Siemens Healthcare Diagnostics Products GmbH	Coagulation Factor II Deficient Plasma 10873878	2024-04-02
GUDID 00842768018848 Siemens Healthcare Diagnostics Products GmbH	Coagulation Factor VII Deficient Plasma 10873879	2024-04-02
GUDID 00842768018831 Siemens Healthcare Diagnostics Products GmbH	Coagulation Factor VIII Deficient Plasma 10873880	2024-04-02
GUDID 00842768018824 Siemens Healthcare Diagnostics Products GmbH	Coagulation Factor IX Deficient Plasma 10873881	2024-04-02
GUDID 00842768018817 Siemens Healthcare Diagnostics Products GmbH	Coagulation Factor X Deficient Plasma 10873882	2024-04-02
GUDID 00842768018749 Siemens Healthcare Diagnostics Products GmbH	Thromborel S 10873931	2024-04-02
GUDID 00842768018725 Siemens Healthcare Diagnostics Products GmbH	Batroxobin Reagent 10873889	2024-04-02
GUDID 00842768018541 Siemens Healthcare Diagnostics Products GmbH	Multifibren U 10873900	2024-04-02
GUDID 00842768018503 Siemens Healthcare Diagnostics Products GmbH	Multifibren U 10873901	2024-04-02
GUDID 00630414640655 Siemens Healthcare Diagnostics Products GmbH	Protein C Reagent 10873871	2024-04-02
GUDID 00630414640631 Siemens Healthcare Diagnostics Products GmbH	Fibrinogen Calibrator Kit 10873868	2024-04-02
GUDID 00630414640532 Siemens Healthcare Diagnostics Products GmbH	Kaolin Suspension 10873859	2024-04-02
GUDID 00630414640501 Siemens Healthcare Diagnostics Products GmbH	INNOVANCE D-Dimer 10873853	2024-04-02
GUDID 00630414640488 Siemens Healthcare Diagnostics Products GmbH	INNOVANCE D-Dimer 10873852	2024-04-02
GUDID 00630414640457 Siemens Healthcare Diagnostics Products GmbH	Protein S Ac 10873846	2024-04-02
GUDID 00630414640389 Siemens Healthcare Diagnostics Products GmbH	Factor VIII Chromogenic Assay 10873840	2024-04-02
GUDID 00630414640181 Siemens Healthcare Diagnostics Products GmbH	INNOVANCE D-Dimer Controls 10873855	2024-04-02
GUDID 00630414640105 Siemens Healthcare Diagnostics Products GmbH	Dade Fibrinogen Determination Reagents 10873937	2024-04-02
GUDID 00630414639864 Siemens Healthcare Diagnostics Products GmbH	INNOVANCE Heparin 10873930	2024-04-02
GUDID 00630414639833 Siemens Healthcare Diagnostics Products GmbH	INNOVANCE Heparin Calibrator 10873925	2024-04-02
GUDID 00630414639826 Siemens Healthcare Diagnostics Products GmbH	INNOVANCE Free PS Ag 10873921	2024-04-02
GUDID 00630414639796 Siemens Healthcare Diagnostics Products GmbH	INNOVANCE Antithrombin 10873911	2024-04-02
GUDID 00630414639758 Siemens Healthcare Diagnostics Products GmbH	Factor V Leiden 10873903	2024-04-02
GUDID 00630414639710 Siemens Healthcare Diagnostics Products GmbH	Berichrom Protein C 10873893	2024-04-02
GUDID 00630414639680 Siemens Healthcare Diagnostics Products GmbH	INNOVANCE Antithrombin 10873910	2024-04-02
GUDID 00630414639673 Siemens Healthcare Diagnostics Products GmbH	INNOVANCE Antithrombin 10873909	2024-04-02
GUDID 00630414639659 Siemens Healthcare Diagnostics Products GmbH	Berichrom Antithrombin III (A) 10873899	2024-04-02
GUDID 00630414639635 Siemens Healthcare Diagnostics Products GmbH	Test Thrombin Reagent 10873894	2024-04-02
GUDID 00630414639628 Siemens Healthcare Diagnostics Products GmbH	Berichrom Protein C 10873892	2024-04-02
GUDID 00630414639468 Siemens Healthcare Diagnostics Products GmbH	INNOVANCE VWF Ac 10873906	2024-04-02
GUDID 00630414639444 Siemens Healthcare Diagnostics Products GmbH	Berichrom Antithrombin III (A) 10873898	2024-04-02
GUDID 00630414639437 Siemens Healthcare Diagnostics Products GmbH	Berichrom a2-Antiplasmin 10873884	2024-04-02
GUDID 00630414639352 Siemens Healthcare Diagnostics Products GmbH	Berichrom Plasminogen 10873885	2024-04-02
GUDID 00630414229546 Siemens Healthcare Diagnostics Products GmbH	INNOVANCE Heparin LMW Control 2 10873928	2024-04-02
GUDID 00630414229539 Siemens Healthcare Diagnostics Products GmbH	INNOVANCE Heparin LMW Control 1 10873929	2024-04-02
GUDID 00630414229522 Siemens Healthcare Diagnostics Products GmbH	INNOVANCE Heparin UF Control 2 10873927	2024-04-02
GUDID 00630414229515 Siemens Healthcare Diagnostics Products GmbH	INNOVANCE Heparin UF Control 1 10873926	2024-04-02
GUDID 00842768018909 Siemens Healthcare Diagnostics Products GmbH	Control Plasma N 10873874	2024-02-27
GUDID 00842768018886 Siemens Healthcare Diagnostics Products GmbH	Coagulation Factor V Deficient Plasma 10873876	2024-02-27
GUDID 00842768018589 Siemens Healthcare Diagnostics Products GmbH	Control Plasma P 10873891	2024-02-27
GUDID 00842768006661 Siemens Healthcare Diagnostics Products GmbH	vWF Ag OPAB03	2023-06-26
GUDID 00842768028014 Siemens Healthcare Diagnostics Products GmbH	INNOVANCE VWF Ac OPHL035	2022-10-18
De Novo DEN200067 Siemens Healthcare Diagnostics Products GmbH	INNOVANCE VWF Ac	2022-09-29
PMN K212379 Siemens Healthcare Diagnostics Products GmbH	N Latex FLC Kappa, N Latex FLC Lambda	2022-03-02
PMN K201496 Siemens Healthcare Diagnostics Products GmbH	N Latex FLC Kappa, N Latex FLC Lambda	2021-10-29
PMN K193047 Siemens Healthcare Diagnostics Products GmbH	N Latex FLC Kappa, N Latex FLC Lambda	2021-07-14
GUDID 00630414287430 Siemens Healthcare Diagnostics Products GmbH	N LP(a) Standard SY OQCV07	2020-10-20
GUDID 00842768021121 Siemens Healthcare Diagnostics Products GmbH	Apolipoprotein Control Serum CHD OUPH09	2020-10-02
GUDID 00842768013317 Siemens Healthcare Diagnostics Products GmbH	N Latex ADNase B OWTI11	2020-10-02
GUDID 00842768011856 Siemens Healthcare Diagnostics Products GmbH	N Antiserum to Human RBP OUVO09	2020-10-02
GUDID 00842768011399 Siemens Healthcare Diagnostics Products GmbH	N Antiserum to Human Prealbumin OUIF09	2020-10-02
GUDID 00842768011207 Siemens Healthcare Diagnostics Products GmbH	Berichrom® Plasminogen OUCA17	2020-10-02
GUDID 00842768008467 Siemens Healthcare Diagnostics Products GmbH	N AS IgG2 OQXK09	2020-10-02
GUDID 00842768008450 Siemens Healthcare Diagnostics Products GmbH	N AS IgG1 OQXI09	2020-10-02
GUDID 00842768008153 Siemens Healthcare Diagnostics Products GmbH	Cleaner SCS OQUB21	2020-10-02
GUDID 00842768007859 Siemens Healthcare Diagnostics Products GmbH	N/T Protein Control LC OQLW15	2020-10-02
GUDID 00842768007781 Siemens Healthcare Diagnostics Products GmbH	BN II Additive OQKY61	2020-10-02
GUDID 00842768007477 Siemens Healthcare Diagnostics Products GmbH	LA 1 Screening Reagent OQGP15	2020-10-02
GUDID 00842768006333 Siemens Healthcare Diagnostics Products GmbH	DImension Vista® Protein 1 Control L (low) KC715	2020-10-02
GUDID 00842768006227 Siemens Healthcare Diagnostics Products GmbH	DImension Vista® Retinol binding Protein K7066	2020-10-02
GUDID 00842768006210 Siemens Healthcare Diagnostics Products GmbH	DImension Vista® Prealbumin Flex® reagent cartridge K7064	2020-10-02
GUDID 00842768006036 Siemens Healthcare Diagnostics Products GmbH	Dimension Vista®Antistreptolysin O Flex® reagent cartridge K7022	2020-10-02
GUDID 00842768006029 Siemens Healthcare Diagnostics Products GmbH	Dimension Vista®Apolipoprotein B Flex® reagent cartridge K7020	2020-10-02
GUDID 00842768006012 Siemens Healthcare Diagnostics Products GmbH	Dimension Vista® Apolipoprotein AI Flex® reagent cartridge K7018	2020-10-02
GUDID 00842768005985 Siemens Healthcare Diagnostics Products GmbH	Dimension Vista® a1-Acid Glycoprotein Flex® reagent cartridge K7012	2020-10-02
GUDID 00842768005978 Siemens Healthcare Diagnostics Products GmbH	Dimension Vista® a1-Microglobulin Flex® reagent cartridge K7010	2020-10-02
GUDID 00630414596563 Siemens Healthcare Diagnostics Products GmbH	Hematek® 3000 System 10805311	2020-10-02
GUDID 00630414287423 Siemens Healthcare Diagnostics Products GmbH	N/T Rheumatology Control SL/2 OQDC17	2020-10-02
GUDID 00630414287416 Siemens Healthcare Diagnostics Products GmbH	N/T Rheumatology Control SL/1 OQDB17	2020-10-02
GUDID 00630414002903 Siemens Healthcare Diagnostics Products GmbH	BN II System OVIA112	2020-10-02
GUDID 00630414002736 Siemens Healthcare Diagnostics Products GmbH	BN ProSpec® System OVLI012	2020-10-02
PMN K190879 Siemens Healthcare Diagnostics Products GmbH	N Latex FLC Kappa, N Latex FLC Lambda	2019-05-03
PMN K182098 Siemens Healthcare Diagnostics Products GmbH	N Latex FLC Kappa Assay, N Latex FLC Lambda Assay	2018-11-01
PMN K181525 Siemens Healthcare Diagnostics Products GmbH	INNOVANCE Free PS Ag	2018-09-07
PMN K171742 Siemens Healthcare Diagnostics Products GmbH	N Latex FLC Kappa Assay, N Latex FLC Lambda Assay, N FLC Standard SL, N FLC Control SL1 & SL2	2017-11-17
PMN K172333 Siemens Healthcare Diagnostics Products GmbH	Sysmex CS-5100	2017-10-31
PMN K171072 Siemens Healthcare Diagnostics Products GmbH	N Latex Cystatin C; N Protein Standard UY	2017-05-12
PMN K162688 Siemens Healthcare Diagnostics Products GmbH	Sysmex CS-2100i	2016-12-26
PMN K162420 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH	Sysmex Automated Blood Coagulation Analyzer CS-5100	2016-12-12
PMN K161317 Siemens Healthcare Diagnostics Products GmbH	Sysmex Automated Blood Coagulation Analyzer CS-5100	2016-09-02
PMN K161312 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH	Sysmex Automated Blood Coagulation Analyzer CS-2100i	2016-09-01
PMN K151259 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH	Sysmex Automated Blood Coagulation Analyzer CS-2100i	2016-01-26

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• Siemens Healthcare Diagnostics Products, LTDglyn Rhonwyllanberis, Caernarfon LL55 PMA NumberP010050 Supplement NumberS021 Date Received09/15/2022 Decision Date10/14/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Siemens Healthcare Diagnostics Products, LTDglyn Rhonwyllanberis, Caernarfon LL55 PMA NumberP010051 Supplement NumberS017 Date Received09/15/2022 Decision Date10/14/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Siemens Healthcare Diagnostics Products, LTDglyn Rhonwyllanberis, Caernarfon LL55 PMA NumberP010052 Supplement NumberS016 Date Received09/15/2022 Decision Date10/14/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Siemens Healthcare Diagnostics Products, LTDglyn Rhonwyllanberis, Caernarfon LL55 PMA NumberP010053 Supplement NumberS016 Date Received09/15/2022 Decision Date10/14/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Siemens Healthcare Diagnostics Products, LTDglyn Rhonwyllanberis, Caernarfon LL55 PMA NumberP010051 Supplement NumberS015 Date Received02/28/2022 Decision Date03/29/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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