SEARCH RESULTS FOR: siemens(7236 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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Fibrinogen Calibrator Kit - 00842768008276

Calibrators for the assay of fibrinogen by the method of Clauss using Multifibren U
Siemens Healthcare Diagnostics Products GmbH
10446148
In Commercial Distribution

  • 00842768008276 ()
OQVK11

  • Fibrinogen assay (factor I) IVD, calibrator

Cleaner SCS - 00842768008153

Cleaning solution BN II, BN ProSpec® Systems and BCS® Systems
Siemens Healthcare Diagnostics Products GmbH
10446136
In Commercial Distribution

  • 00842768008153 ()
  • 00842768018930 ()
OQUB21

  • Wash/cleaning solution IVD, automated/semi-automated system

N Latex Ferritin - 00842768008085

Quantitative determination of ferritin in human serum and heparinized plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446130
In Commercial Distribution

  • 00842768008085 ()
OQTH11

  • Ferritin IVD, kit, nephelometry/turbidimetry

N Latex IgE mono - 00842768008078

Quantitative determination of IgE in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446129
In Commercial Distribution

  • 00842768008078 ()
  • 00842768018947 ()
OQTG15

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, nephelometry/turbidimetry

N Supplementary Reagent L - 00842768008061

Supplementary reagent for multiple protein assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446128
In Commercial Distribution

  • 00842768008061 ()
OQTD11

  • Immunoglobulin removal reagent IVD

N Latex sTfR - 00842768008054

Quantitative determination of soluble transferrin receptor (sTfR) in human serum and heparinized plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446127
In Commercial Distribution

  • 00842768008054 ()
  • 00842768018954 ()
OQTC11

  • Soluble transferrin receptor IVD, reagent

BC Validation Kit - 00842768008023

Check of the proper functioning and precision of the pipettors on the BCS® System, the BCS® XP System and the BCT System
Siemens Healthcare Diagnostics Products GmbH
10446125
In Commercial Distribution

  • 00842768008023 ()
OQSC11

  • Optical laboratory instrument performance standard calibrator/control IVD, single-use

Neodisher® GK - 00842768008009

Cleaning agent for laboratory use
Siemens Healthcare Diagnostics Products GmbH
10446123
In Commercial Distribution

  • 00842768008009 ()
OQRK51

  • Wash/cleaning solution IVD, manual equipment

ProC® Control Plasma - 00842768007774

Assayed control to monitor the performance of Factor V Leiden assay in the pathological range
Siemens Healthcare Diagnostics Products GmbH
10446097
In Commercial Distribution

  • 00842768007774 ()
  • 00842768019005 ()
OQKE19

  • Protein C IVD, control

N Protein Standard SL - 00842768007590

N Protein Standard SL is a multi-analyte calibrator for the establishment of reference curves on the Siemens Systems
Siemens Healthcare Diagnostics Products GmbH
10446073
In Commercial Distribution

  • 00842768007590 ()
  • 00842768019050 ()
OQIM13

  • Plasma protein IVD, calibrator

N Latex Lp(a) Reagent - 00842768007552

Quantitative determination of Lp(a) in human serum and heparinized plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446069
In Commercial Distribution

  • 00842768007552 ()
  • 00842768019067 ()
OQHL11

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry

Pathromtin® SL - 00842768007538

Determination of the activated partial thromboplastin time (APTT) in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10446067
In Commercial Distribution

  • 00842768007538 ()
  • 00842768019074 ()
OQGS35

  • Activated partial thromboplastin time (APTT) IVD, reagent

Pathromtin® SL - 00842768007521

Determination of the activated partial thromboplastin time (APTT) in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10446066
In Commercial Distribution

  • 00842768007521 ()
  • 00842768019074 ()
OQGS29

  • Activated partial thromboplastin time (APTT) IVD, reagent

LA 2 Confirmation Reagent - 00842768007491

LA 2 Confirmation Reagent. Phospholipid-rich DRVV reagent for the specific correction of Lupus Anticoagulants
Siemens Healthcare Diagnostics Products GmbH
10458687
In Commercial Distribution

  • 00842768007491 ()
  • 00842768019661 ()
OQGR11

  • Lupus anticoagulant marker IVD, reagent

LA 1 Screening Reagent - 00842768007477

LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence of Lupus Anticoagulants
Siemens Healthcare Diagnostics Products GmbH
10461887
In Commercial Distribution

  • 00842768007477 ()
  • 00842768019654 ()
OQGP15

  • Lupus anticoagulant marker IVD, reagent

N Antiserum to Human C1-Inhibitor - 00842768007323

Quantitative determination of C1 Inhibitor in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446049
In Commercial Distribution

  • 00842768007323 ()
OQEY09

  • Complement component C1 inhibitor IVD, kit, nephelometry/turbidimetry

N Lp(a) Control SY - 00842768007248

Assayed control for Lp(a) assay on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446040
In Commercial Distribution

  • 00842768007248 ()
  • 00842768019104 ()
OQCW05

  • Lipoprotein A IVD, control

N Latex IgA - 00842768007200

Quantitative determination of IgA in human CSF and paired CSF/serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446036
In Commercial Distribution

  • 00842768007200 ()
OQAI11

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

Kaolin Suspension - 00842768007170

Supplementary Reagent for coagulation tests
Siemens Healthcare Diagnostics Products GmbH
10446033
In Commercial Distribution

  • 00842768007170 ()
OQAB45

  • Fibrinogen assay (factor I) IVD, reagent

N Latex RF Kit - 00842768006883

Determination of Rheumatoid factors (RF) in human serum and plasma on the BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10445991
In Commercial Distribution

  • 00842768006883 ()
OPCE03

  • Rheumatoid factor IVD, kit, nephelometry/turbidimetry

Berichrom® Heparin LMW Control 1 - 00842768006876

For use as a low level assayed control for the quantitative measurement of low molecular weight heparin with Berichrom Heparin
Siemens Healthcare Diagnostics Products GmbH
10445990
Not in Commercial Distribution

  • 00842768006876 ()
  • 00842768019180 ()
OPCD03

  • Multiple coagulation factor IVD, control

Berichrom® Heparin UF Calibrator - 00842768006869

For calibration of the Berichrom Heparin assay for measurement of unfractionated heparin
Siemens Healthcare Diagnostics Products GmbH
10445989
Not in Commercial Distribution

  • 00842768006869 ()
  • 00842768019197 ()
OPCC03

  • Heparin anti-Xa IVD, calibrator

Berichrom® Heparin LMW Control 2 - 00842768006852

For use as a high level assayed control for the quantitative measurement of low molecular weight heparin with Berichrom Heparin
Siemens Healthcare Diagnostics Products GmbH
10445988
Not in Commercial Distribution

  • 00842768006852 ()
  • 00842768019203 ()
OPCB03

  • Multiple coagulation factor IVD, control

Berichrom® Heparin LMW Calibrator - 00842768006845

For calibration of the Berichrom Heparin assay for measurement of low molecular weight heparin
Siemens Healthcare Diagnostics Products GmbH
10445987
Not in Commercial Distribution

  • 00842768006845 ()
  • 00842768019210 ()
OPCA03

  • Heparin anti-Xa IVD, calibrator

Berichrom® Heparin UF Control 1 - 00842768006821

For use as a low level assayed control for the quantitative measurement of unfractionated heparin with Berichrom Heparin
Siemens Healthcare Diagnostics Products GmbH
10445985
Not in Commercial Distribution

  • 00842768006821 ()
  • 00842768019234 ()
OPBY03

  • Multiple coagulation factor IVD, control

N Latex ASL - 00842768006807

Determination of Anti-Streptotysin O (ASL) in human serum and plasma on BN II and BN ProSpec Systems
Siemens Healthcare Diagnostics Products GmbH
10445984
In Commercial Distribution

  • 00842768006807 ()
  • 00842768019241 ()
OPBU05

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry

N Latex ASL - 00842768006791

Determination of Anti-Streptotysin O (ASL) in human serum and plasma on BN II and BN ProSpec Systems
Siemens Healthcare Diagnostics Products GmbH
10445983
In Commercial Distribution

  • 00842768006791 ()
  • 00842768019258 ()
OPBU03

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry

Enzygnost® F1+2 monoclonal - 00842768006760

Quantitative determination of prothrombin fragment F 1+2 in human plasma
Siemens Healthcare Diagnostics Products GmbH
10445978
In Commercial Distribution

  • 00842768006760 ()
OPBD03

  • Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA)

DImension Vista® Protein 2 Calibrator - 00842768006463

For the calibration of ASL, CRP, hsCRP and RF methods on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445935
In Commercial Distribution

  • 00842768006463 ()
  • 00842768019296 ()
KC780

  • Plasma protein IVD, calibrator

DImension Vista® Protein 3 Calibrator - 00842768006449

For the calibration of the A1MIC, CYSC, MALB and sALB (for serum, plasma and cerebrospinal fluid) methods on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445931
In Commercial Distribution

  • 00842768006449 ()
  • 00842768019319 ()
KC770

  • Plasma protein IVD, calibrator

DImension Vista® High Sensitivity CPR Control L (low) - 00842768006425

For use as an assayed intralaboratory control for assessment of precision and analytical bias in the determination of the hsCRP method on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445929
In Commercial Distribution

  • 00842768006425 ()
  • 00842768019333 ()
KC755

  • C-reactive protein (CRP) IVD, control

DImension Vista® C1 Inhibitor Control - 00842768006418

C1IN CON is an assayed, mid level, intralaboratory quality control for the assessment of precision and analytical bias in the determination of the C1IN method on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445927
Not in Commercial Distribution

  • 00842768006418 ()
  • 00842768019340 ()
KC745

  • Plasma protein IVD, control

DImension Vista® Cystatin C Control H (high) - 00842768006395

CYSC CON H is an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of the CYSC method on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445925
In Commercial Distribution

  • 00842768006395 ()
  • 00842768019364 ()
KC737

  • Plasma protein IVD, control

DImension Vista® Apolipoprotein Control - 00842768006371

APO CON is an assayed intralaboratory quality control for the assessment of precision and analytical bias in the determination of APOAI and APOB methods on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445923
In Commercial Distribution

  • 00842768006371 ()
  • 00842768019388 ()
KC725

  • Plasma protein IVD, control

DImension Vista® Apolipoprotein Calibrator - 00842768006364

For the calibration of APOAI and APOB methods on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445922
In Commercial Distribution

  • 00842768006364 ()
  • 00842768019395 ()
KC720

  • Plasma protein IVD, calibrator

DImension Vista® Protein 1 Control M (medium) - 00842768006340

PROT1 CON M is an assayed, mid-level, intralaboratory, multi-analyte quality control for the assessment of precision and analytical bias on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445920
In Commercial Distribution

  • 00842768006340 ()
  • 00842768019425 ()
KC716

  • Plasma protein IVD, control

DImension Vista® Protein 1 Control L (low) - 00842768006333

PROT1 CON L is an assayed, low level, intralaboratory, multi-analyte quality control for the assessment of precision and analytical bias on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445919
In Commercial Distribution

  • 00842768006333 ()
  • 00842768019432 ()
KC715

  • Plasma protein IVD, control

DImension Vista® C1 Inhibitor Flex® Reagent Cartridge - 00842768006302

For the quantitative measurement of C1 inhibitor in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445915
Not in Commercial Distribution

  • 00842768006302 ()
  • 00842768020247 ()
K7086

  • Complement component C1 inhibitor IVD, kit, nephelometry/turbidimetry

DImension Vista® Immunoglobulin G Subclass 3 Flex® reagent cartridge - 00842768006289

For the quantitative measurement of immunoglobulin G subclass 3 in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445913
In Commercial Distribution

  • 00842768006289 ()
  • 00842768020209 ()
K7082

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

DImension Vista® Immunoglobulin G Subclass 2 Flex® reagent cartridge - 00842768006272

For the quantitative measurement of immunoglobulin G subclass 2 in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445912
In Commercial Distribution

  • 00842768006272 ()
  • 00842768020193 ()
K7081

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent
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