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 Registration(s)

FDA Filings

Device
Company
DeviceDate
Siemens Healthcare Diagnostics Products GmbH
INNOVANCE VWF Ac OPHL0352022-10-18
Siemens Healthcare Diagnostics Products GmbH
INNOVANCE VWF Ac2022-09-29
Siemens Healthcare Diagnostics Products GmbH
N Latex FLC Kappa, N Latex FLC Lambda2022-03-02
Siemens Healthcare Diagnostics Products GmbH
N Latex FLC Kappa, N Latex FLC Lambda2021-10-29
Siemens Healthcare Diagnostics Products GmbH
N Latex FLC Kappa, N Latex FLC Lambda2021-07-14
Siemens Healthcare Diagnostics Products GmbH
N LP(a) Standard SY OQCV072020-10-20
Siemens Healthcare Diagnostics Products GmbH
IMMULITE® Probe Cleaning Kit LKPM2020-10-02
Siemens Healthcare Diagnostics Products GmbH
IMMULITE® 2000/IMMULITE® 2500 Probe Cleaning Kit L2KPM2020-10-02
Siemens Healthcare Diagnostics Products GmbH
IMMULITE® 2000 / IMMULITE® 2500 Probe Wash Module L2PWSM2020-10-02
Siemens Healthcare Diagnostics Products GmbH
IMMULITE® Probe Wash Module LPWS22020-10-02
Siemens Healthcare Diagnostics Products GmbH
Dimension Vista® PROT3 CON KC775U2020-10-02
Siemens Healthcare Diagnostics Products GmbH
Apolipoprotein Control Serum CHD OUPH092020-10-02
Siemens Healthcare Diagnostics Products GmbH
N Latex CDT Kit OPCS052020-10-02
Siemens Healthcare Diagnostics Products GmbH
N/T Protein Control SL/M OQIO192020-10-02
Siemens Healthcare Diagnostics Products GmbH
N/T Protein Control SL/L OQIN192020-10-02
Siemens Healthcare Diagnostics Products GmbH
N/T Protein Control SL/H OQIP192020-10-02
Siemens Healthcare Diagnostics Products GmbH
N Latex ADNase B OWTI112020-10-02
Siemens Healthcare Diagnostics Products GmbH
N Antiserum to Human RBP OUVO092020-10-02
Siemens Healthcare Diagnostics Products GmbH
N Antiserum to Human Prealbumin OUIF092020-10-02
Siemens Healthcare Diagnostics Products GmbH
Berichrom® Plasminogen OUCA172020-10-02
Siemens Healthcare Diagnostics Products GmbH
N AS IgG2 OQXK092020-10-02
Siemens Healthcare Diagnostics Products GmbH
N AS IgG1 OQXI092020-10-02
Siemens Healthcare Diagnostics Products GmbH
Cleaner SCS OQUB212020-10-02
Siemens Healthcare Diagnostics Products GmbH
Neodisher® GK OQRK512020-10-02
Siemens Healthcare Diagnostics Products GmbH
N/T Protein Control LC OQLW152020-10-02
Siemens Healthcare Diagnostics Products GmbH
BN II Additive OQKY612020-10-02
Siemens Healthcare Diagnostics Products GmbH
LA 2 Confirmation Reagent OQGR112020-10-02
Siemens Healthcare Diagnostics Products GmbH
LA 1 Screening Reagent OQGP152020-10-02
Siemens Healthcare Diagnostics Products GmbH
N/T Rheumatology Control SL/2 OQDC132020-10-02
Siemens Healthcare Diagnostics Products GmbH
N/T Rheumatology Control SL/1 OQDB132020-10-02
Siemens Healthcare Diagnostics Products GmbH
N Lp(a) Control SY OQCW052020-10-02
Siemens Healthcare Diagnostics Products GmbH
Imidazole Buffer Solution OQAA332020-10-02
Siemens Healthcare Diagnostics Products GmbH
N Latex ASL OPBU052020-10-02
Siemens Healthcare Diagnostics Products GmbH
N Latex ASL OPBU032020-10-02
Siemens Healthcare Diagnostics Products GmbH
N Latex IgG3 OPAV032020-10-02
Siemens Healthcare Diagnostics Products GmbH
N Latex IgG4 OPAU032020-10-02
Siemens Healthcare Diagnostics Products GmbH
DImension Vista® Protein 2 Control H KC7872020-10-02
Siemens Healthcare Diagnostics Products GmbH
DImension Vista® Protein 2 Control L KC7852020-10-02
Siemens Healthcare Diagnostics Products GmbH
DImension Vista® High Sensitivity CRP Control H (high) KC7572020-10-02
Siemens Healthcare Diagnostics Products GmbH
DImension Vista® High Sensitivity CPR Control L (low) KC7552020-10-02
Siemens Healthcare Diagnostics Products GmbH
DImension Vista® C1 Inhibitor Control KC7452020-10-02
Siemens Healthcare Diagnostics Products GmbH
DImension Vista® Cystatin C Control H (high) KC7372020-10-02
Siemens Healthcare Diagnostics Products GmbH
DImension Vista® Cystatin C Control L (low) KC7352020-10-02
Siemens Healthcare Diagnostics Products GmbH
DImension Vista® Apolipoprotein Control KC7252020-10-02
Siemens Healthcare Diagnostics Products GmbH
DImension Vista® Protein 1 Control M (medium) KC7162020-10-02
Siemens Healthcare Diagnostics Products GmbH
DImension Vista® Protein 1 Control L (low) KC7152020-10-02
Siemens Healthcare Diagnostics Products GmbH
DImension Vista® Retinol binding Protein K70662020-10-02
Siemens Healthcare Diagnostics Products GmbH
DImension Vista® Prealbumin Flex® reagent cartridge K70642020-10-02
Siemens Healthcare Diagnostics Products GmbH
Dimension Vista®Antistreptolysin O Flex® reagent cartridge K70222020-10-02
Siemens Healthcare Diagnostics Products GmbH
Dimension Vista®Apolipoprotein B Flex® reagent cartridge K70202020-10-02
Siemens Healthcare Diagnostics Products GmbH
Dimension Vista® Apolipoprotein AI Flex® reagent cartridge K70182020-10-02
Siemens Healthcare Diagnostics Products GmbH
Dimension Vista® a1-Acid Glycoprotein Flex® reagent cartridge K70122020-10-02
Siemens Healthcare Diagnostics Products GmbH
Dimension Vista® a1-Microglobulin Flex® reagent cartridge K70102020-10-02
Siemens Healthcare Diagnostics Products GmbH
Hematek® 3000 System 108053112020-10-02
Siemens Healthcare Diagnostics Products GmbH
N/T Rheumatology Control SL/2 OQDC172020-10-02
Siemens Healthcare Diagnostics Products GmbH
N/T Rheumatology Control SL/1 OQDB172020-10-02
Siemens Healthcare Diagnostics Products GmbH
BN II System OVIA1122020-10-02
Siemens Healthcare Diagnostics Products GmbH
BN ProSpec® System OVLI0122020-10-02
Siemens Healthcare Diagnostics Products GmbH
N Latex ADNase B (USA) OWTI152020-07-15
Siemens Healthcare Diagnostics Products GmbH
N Latex IgA OQAI152020-07-01
Siemens Healthcare Diagnostics Products GmbH
N Lp(a) Control SY OQCW072020-06-08
Siemens Healthcare Diagnostics Products GmbH
N Latex Myoglobin OWIA172020-06-08
Siemens Healthcare Diagnostics Products GmbH
N Latex IgM OQAC152020-06-08
Siemens Healthcare Diagnostics Products GmbH
INNOVANCE Antithrombin OPFH112020-05-15
Siemens Healthcare Diagnostics Products GmbH
N Rheumatology Standard SL OQKZ152020-02-24
Siemens Healthcare Diagnostics Products GmbH
N Protein Standard SL OQIM192019-12-17
Siemens Healthcare Diagnostics Products GmbH
N FLC CONTROL SL2 OPJF052019-05-27
Siemens Healthcare Diagnostics Products GmbH
N FLC STANDARD SL OPJD052019-05-27
Siemens Healthcare Diagnostics Products GmbH
N FLC SUPPLEMENTARY REAGENT OPJC052019-05-27
Siemens Healthcare Diagnostics Products GmbH
N LATEX FLC KAPPA OPJA0752019-05-20
Siemens Healthcare Diagnostics Products GmbH
N Latex FLC Kappa, N Latex FLC Lambda2019-05-03
Siemens Healthcare Diagnostics Products GmbH
RapiTex® ASL OWHP212019-01-28
Siemens Healthcare Diagnostics Products GmbH
RapiTex® ASL OUBA432019-01-28
Siemens Healthcare Diagnostics Products GmbH
RapiTex® ASL OUBA312019-01-28
Siemens Healthcare Diagnostics Products GmbH
INNOVANCE Free PS Ag OPGL072018-12-17
Siemens Healthcare Diagnostics Products GmbH
N LATEX FLC lambda OPJB072018-11-19
Siemens Healthcare Diagnostics Products GmbH
BC Validation Kit OQSC112018-11-08
Siemens Healthcare Diagnostics Products GmbH
N FLC CONTROL SL1 OPJE052018-11-08
Siemens Healthcare Diagnostics Products GmbH
N Latex FLC Kappa Assay, N Latex FLC Lambda Assay2018-11-01
Siemens Healthcare Diagnostics Products GmbH
Diff-Quik™ Fixative B4132-10A2018-10-25
Siemens Healthcare Diagnostics Products GmbH
Diff-Quik™ Stain Set B4132-1A2018-10-25
Siemens Healthcare Diagnostics Products GmbH
Diff-Quik™ Solution II B4132-12A2018-10-25
Siemens Healthcare Diagnostics Products GmbH
Diff-Quik™ Solution I B4132-11A2018-10-25
Siemens Healthcare Diagnostics Products GmbH
INNOVANCE Free PS Ag2018-09-07
Siemens Healthcare Diagnostics Products GmbH
Dade® Hepzyme® B4240-102018-07-06
Siemens Healthcare Diagnostics Products GmbH
Factor VIII Chromogenic Assay B4238-402018-07-06
Siemens Healthcare Diagnostics Products GmbH
Dade® Cluster® Platelet Aggregation Reagents B4236-12018-07-06
Siemens Healthcare Diagnostics Products GmbH
Dade® Owren's Veronal Buffer B4234-252018-07-06
Siemens Healthcare Diagnostics Products GmbH
Dade® DIMERTEST® Latex Beads B4233-61L2018-07-06
Siemens Healthcare Diagnostics Products GmbH
Dade® DIMERTEST® Latex Assay B4233-602018-07-06
Siemens Healthcare Diagnostics Products GmbH
Dade® Thrombin Reagent B4233-272018-07-06
Siemens Healthcare Diagnostics Products GmbH
Dade® Thrombin Reagent B4233-252018-07-06
Siemens Healthcare Diagnostics Products GmbH
Dade® Data-Fi® Abnormal Fibrinogen Control B4233-222018-07-06
Siemens Healthcare Diagnostics Products GmbH
Dade® Ci-Trol® Heparin Control, High B4224-602018-07-06
Siemens Healthcare Diagnostics Products GmbH
Dade® Ci-Trol® Heparin Control, Low B4224-502018-07-06
Siemens Healthcare Diagnostics Products GmbH
Dade® Actin® FSL Activated PTT Reagent B4219-22018-07-06
Siemens Healthcare Diagnostics Products GmbH
Dade® Actin® FSL Activated PTT Reagent B4219-12018-07-06
Siemens Healthcare Diagnostics Products GmbH
Dade® Actin® FS Activated PTT Reagent B4218-202018-07-06
Siemens Healthcare Diagnostics Products GmbH
Dade® Actin® Activated Cephaloplastin Reagent B4218-22018-07-06
Siemens Healthcare Diagnostics Products GmbH
Dade® Actin® FS Activated PTT Reagent B4218-1002018-07-06
Siemens Healthcare Diagnostics Products GmbH
Dade® Actin® Activated Cephaloplastin Reagent B4218-12018-07-06
Siemens Healthcare Diagnostics Products GmbH
Dade® Innovin® B4212-502018-07-06
Siemens Healthcare Diagnostics Products GmbH
Dade® Innovin® B4212-402018-07-06
Siemens Healthcare Diagnostics Products GmbH
Dade® Innovin® B4212-1002018-07-06
Siemens Healthcare Diagnostics Products GmbH
Dade® PFA Trigger Solution B4170-502018-07-06
Siemens Healthcare Diagnostics Products GmbH
Dade® PFA Collagen/ADP Test Cartridge B4170-21A2018-07-06
Siemens Healthcare Diagnostics Products GmbH
Dade® PFA Collagen/EPI Test Cartridge B4170-20A2018-07-06
Siemens Healthcare Diagnostics Products GmbH
N Latex FLC Kappa Assay, N Latex FLC Lambda Assay, N FLC Standard SL, N FLC Control SL1 & SL22017-11-17
Siemens Healthcare Diagnostics Products GmbH
Sysmex CS-51002017-10-31
Siemens Healthcare Diagnostics Products GmbH
N Latex Cystatin C; N Protein Standard UY2017-05-12
Siemens Healthcare Diagnostics Products GmbH
Sysmex CS-2100i2016-12-26
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Sysmex Automated Blood Coagulation Analyzer CS-51002016-12-12
Siemens Healthcare Diagnostics Products GmbH
Sysmex Automated Blood Coagulation Analyzer CS-51002016-09-02
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Sysmex Automated Blood Coagulation Analyzer CS-2100i2016-09-01
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Sysmex Automated Blood Coagulation Analyzer CS-2100i2016-01-26

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