SEARCH RESULTS FOR: siemens(7217 results)

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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Dade Ci-Trol Coagulation Control Level 3 - 00630414640426

For use as control in citrated coagulation systems
Siemens Healthcare Diagnostics Products GmbH
10873844
In Commercial Distribution

  • 00842768019456 ()
  • 00630414640426 ()
10873844

  • Multiple coagulation factor IVD, control

Factor VIII Chromogenic Assay - 00630414640389

Determination of Factor VIII (antihemophilic factor) activity in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873840
In Commercial Distribution

  • 00630414640389 ()
10873840

  • Coagulation factor VIII IVD, kit, chromogenic

Dade Ci-Trol Heparin Control, High - 00630414640365

Control in heparin assay procedures
Siemens Healthcare Diagnostics Products GmbH
10873834
In Commercial Distribution

  • 00842768019531 ()
  • 00630414640365 ()
10873834

  • Multiple coagulation factor IVD, control

Dade Actin FSL Activated PTT Reagent - 00630414640358

Liquid purified soy and rabbit brain phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10873832
In Commercial Distribution

  • 00842768019555 ()
  • 00630414640358 ()
10873832

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade Actin FS Activated PTT Reagent - 00630414640341

Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10873830
In Commercial Distribution

  • 00842768019562 ()
  • 00630414640341 ()
10873830

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade Actin Activated Cephaloplastin Reagent - 00630414640334

Liquid rabbit brain cephalin with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10873829
In Commercial Distribution

  • 00842768019579 ()
  • 00630414640334 ()
10873829

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade Actin FS Activated PTT Reagent - 00630414640327

Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10873828
In Commercial Distribution

  • 00842768019562 ()
  • 00630414640327 ()
10873828

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade Actin Activated Cephaloplastin Reagent - 00630414640310

Liquid rabbit brain cephalin with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10873827
In Commercial Distribution

  • 00842768019579 ()
  • 00630414640310 ()
10873827

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade Ci-Trol Coagulation Control Level 2 - 00630414640280

For use as control in citrated coagulation systems
Siemens Healthcare Diagnostics Products GmbH
10873843
In Commercial Distribution

  • 00842768019463 ()
  • 00630414640280 ()
10873843

  • Multiple coagulation factor IVD, control

Dade Thrombin Reagent - 00630414640266

Determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies
Siemens Healthcare Diagnostics Products GmbH
10873837
In Commercial Distribution

  • 00842768019517 ()
  • 00630414640266 ()
10873837

  • Fibrinogen assay (factor I) IVD, reagent

Dade Actin FSL Activated PTT Reagent - 00630414640242

Liquid purified soy and rabbit brain phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10873831
In Commercial Distribution

  • 00842768019555 ()
  • 00630414640242 ()
10873831

  • Activated partial thromboplastin time (APTT) IVD, reagent

LA Control Low - 00630414640013

LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays
Siemens Healthcare Diagnostics Products GmbH
10873935
In Commercial Distribution

  • 00842768019678 ()
  • 00630414640013 ()
10873935

  • Lupus anticoagulant marker IVD, control

Dade Innovin - 00630414640006

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873933
In Commercial Distribution

  • 00842768019586 ()
  • 00630414640006 ()
10873933

  • Prothrombin time (PT) IVD, reagent

Thromborel S - 00630414639963

Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and X
Siemens Healthcare Diagnostics Products GmbH
10873931
In Commercial Distribution

  • 00842768018749 ()
  • 00630414639963 ()
10873931

  • Prothrombin time (PT) IVD, reagent

INNOVANCE Heparin LMW Control 1 - 00630414639956

For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873929
In Commercial Distribution

  • 00630414229539 ()
  • 00630414639956 ()
10873929

  • Heparin anti-Xa IVD, control

INNOVANCE Heparin UF Control 1 - 00630414639949

For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873926
In Commercial Distribution

  • 00630414229515 ()
  • 00630414639949 ()
10873926

  • Heparin anti-Xa IVD, control

Dade CA System Buffer - 00630414639901

For coagulation tests and as a rinsing solution for the sample needles of the Sysmex® CA Systems
Siemens Healthcare Diagnostics Products GmbH
10873915
In Commercial Distribution

  • 00842768019845 ()
  • 00630414639901 ()
10873915

  • Buffered sample diluent IVD

Dade Innovin - 00630414639888

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873934
In Commercial Distribution

  • 00842768019609 ()
  • 00630414639888 ()
10873934

  • Prothrombin time (PT) IVD, reagent

Dade Innovin - 00630414639871

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873932
In Commercial Distribution

  • 00842768019593 ()
  • 00630414639871 ()
10873932

  • Prothrombin time (PT) IVD, reagent

INNOVANCE Heparin - 00630414639864

For the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH)
Siemens Healthcare Diagnostics Products GmbH
10873930
In Commercial Distribution

  • 00630414639864 ()
10873930

  • Heparin anti-Xa IVD, kit, chromogenic

INNOVANCE Heparin LMW Control 2 - 00630414639857

For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873928
In Commercial Distribution

  • 00630414229546 ()
  • 00630414639857 ()
10873928

  • Heparin anti-Xa IVD, control

INNOVANCE Heparin Calibrator - 00630414639833

For calibration of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873925
In Commercial Distribution

  • 00630414639833 ()
10873925

  • Heparin anti-Xa IVD, calibrator

INNOVANCE Antithrombin - 00630414639796

Chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10873911
In Commercial Distribution

  • 00630414639796 ()
10873911

  • Antithrombin III (ATIII) IVD, kit, chromogenic

Berichrom a2-Antiplasmin - 00630414639437

Quantative determination of a2-antiplasmin activity as an aid in the diagnosis of inherited or acquired deficiencies and in management of fibrinolytic therapy
Siemens Healthcare Diagnostics Products GmbH
10873884
In Commercial Distribution

  • 00630414639437 ()
10873884

  • Alpha-2-antiplasmin IVD, kit, chromogenic

Atellica IM HBcT2 QC - 00630414604336

HBc Total 2 (HBcT2) Atellica IM - CLT 2 x 2 x 7.0mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11200740
In Commercial Distribution

  • 00630414604336 ()
11200740

  • Hepatitis B virus core total antibody IVD, control

Atellica IM HBcT2 - 00630414604138

HBc Total 2 (HBcT2) Atellica IM - RGT 100T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11200739
In Commercial Distribution

  • 00630414604138 ()
11200739

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems CCP Anti-CCP IgG - 00630414601991

CCP IgG Ab - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10718148
In Commercial Distribution

  • 00630414601991 ()
L2KPI2(D)

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay

IMMULITE® Systems PTS Calibration Verification Material PSA - 00630414601946

PSA CVM - IMMULITE – CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10713726
In Commercial Distribution

  • 00630414601946 ()
LPTSCVM

  • Complexed prostate specific antigen (cPSA) IVD, control

IMMULITE® 3RD GEN. PSA CVM - 00630414601939

3rd Generation PSA CVM - IMMULITE – CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10713725
In Commercial Distribution

  • 00630414601939 ()
L3PSCVM

  • Total prostate specific antigen (tPSA) IVD, control

IMMULITE®/IMMULITE® 1000 Systems IGF-I - 00630414601243

Insulin-like growth factor I (IGF-I) 100 test kit
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11128584
In Commercial Distribution

  • 00630414601243 ()
LKIGF1

  • Insulin-like growth factor I (IGF1) IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems IGF-I - 00630414601236

Insulin-like growth factor I (IGF-I) 200 test kit
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11128543
In Commercial Distribution

  • 00630414601236 ()
L2KIGF2

  • Insulin-like growth factor I (IGF1) IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 TSI - 00630414597188

IMMULITE(R) 2000 TSI Assay
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10876421
In Commercial Distribution

  • 00630414597188 ()
L2KSI2(D)

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, chemiluminescent immunoassay

Hematek® 3000 System - 00630414596563

The Hematek slide stainer is a fully automated, bench-top hematology system for in vitro diagnostic use in the clinical laboratoy
Siemens Healthcare Diagnostics Products GmbH
10805311
In Commercial Distribution

  • 00630414596563 ()
10805311

  • Microscope slide stainer IVD

IMMULITE® 2000 Systems FT4 Free T4 - 00630414996851

Free T4 - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381677
In Commercial Distribution

  • 00630414996851 ()
L2KFT46

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems FT4 Free T4 - 00630414996844

Free T4 - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381678
In Commercial Distribution

  • 00630414996844 ()
L2KFT42

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay

IMMULITE® Systems PAP CONTROL PAP - 00630414996639

PAP - IMMULITE - CTL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385588
In Commercial Distribution

  • 00630414996639 ()
PACM

  • Prostatic acid phosphatase (PAP) IVD, control

IMMULITE®2000 Systems 3gAllergy™ Mouse Urine - 00630414996615

Mouse Urine -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385657
In Commercial Distribution

  • 00630414996615 ()
E72L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE®2000 Systems 3gAllergy™ Rat Urine - 00630414996608

Rat Urine Proteins -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385659
In Commercial Distribution

  • 00630414996608 ()
E74L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE®2000 Systems 3gAllergy™ Rat Serum Proteins - 00630414996592

Rat Serum Proteins -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385660
In Commercial Distribution

  • 00630414996592 ()
E75L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE®2000 Systems 3gAllergy™ Mouse Serum Protein - 00630414996585

Mouse Serum Proteins -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385661
In Commercial Distribution

  • 00630414996585 ()
E76L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
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