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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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N AS IgG1 - 00842768008450

Quantitative determination of IgG subclass 1 in human serum on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10446168
In Commercial Distribution

  • 00842768008450 ()
OQXI09

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

LA Control Low - 00842768008368

LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays, specifically LA 1 Screening Reagent (DRVVT) and LA 2 Confirmation Reagent (DRVVT) from Siemens Healthcare Diagnostics on automated coagulation analyzers
Siemens Healthcare Diagnostics Products GmbH
10446154
Not in Commercial Distribution

  • 00842768008368 ()
  • 00842768019678 ()
OQWE11

  • Multiple coagulation factor IVD, control

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

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

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

N Latex Cystatin C - 00842768007934

Quantitative determination of cystatin C in human serum and heparinized plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446116
In Commercial Distribution

  • 00842768007934 ()
OQNM13

  • Cystatin C IVD, kit, nephelometry/turbidimetry

N Protein Standard UY - 00842768007835

Calibration of Human a1-microglobulin and cystatin C assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446103
In Commercial Distribution

  • 00842768007835 ()
  • 00842768018978 ()
OQLV09

  • Plasma protein IVD, calibrator

BN II Additive - 00842768007781

Washing Solution (concentrate) for cleaning the cuvettes in the BN II System
Siemens Healthcare Diagnostics Products GmbH
10446098
In Commercial Distribution

  • 00842768007781 ()
  • 00842768018992 ()
OQKY61

  • Buffered wash solution IVD

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 Lp(a) Standard SY - 00842768007224

Calibration of Lp(a) assay on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446038
In Commercial Distribution

  • 00842768007224 ()
  • 00842768019111 ()
OQCV05

  • Lipoprotein A IVD, calibrator

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

Imidazole Buffer Solution - 00842768007163

Imidazole Buffer Solution is used as diluent for various coagulation assays
Siemens Healthcare Diagnostics Products GmbH
10446032
In Commercial Distribution

  • 00842768007163 ()
  • 00842768019135 ()
OQAA33

  • Buffered sample diluent IVD

N Latex RF Kit - 00842768006890

Determination of Rheumatoid Factors (RF) in human serum and plasma on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10445992
In Commercial Distribution

  • 00842768006890 ()
OPCE05

  • Rheumatoid factor IVD, kit, nephelometry/turbidimetry

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 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 2 - 00842768006838

For use as a high level assayed control for the quantitative measurement of unfractionated heparin with Berichrom Heparin
Siemens Healthcare Diagnostics Products GmbH
10445986
Not in Commercial Distribution

  • 00842768006838 ()
  • 00842768019227 ()
OPBZ03

  • Multiple coagulation factor IVD, control

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)

N Latex HCY - 00842768006715

Quantitative determination of homocysteine in human serum and plasma on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10445973
In Commercial Distribution

  • 00842768006715 ()
OPAX03

  • Homocysteine IVD, reagent

N Latex IgG3 - 00842768006708

Quantitative determination of IgG subclass 3 in human serum and plasma on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10445972
In Commercial Distribution

  • 00842768006708 ()
OPAV03

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

N Latex IgG4 - 00842768006692

Quantitative determination of IgG subclass 4 in human serum and plasma on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10445971
In Commercial Distribution

  • 00842768006692 ()
OPAU03

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

Protein S Ac - 00842768006678

Determination of the functional activity of protein S in human plasma
Siemens Healthcare Diagnostics Products GmbH
10445968
In Commercial Distribution

  • 00842768006678 ()
OPAP03

  • Protein S IVD, kit, clotting

vWF Ag - 00842768006661

For the quantitative determination of von Willebrand factor (vWF) antigen concentration in human sodium citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10445967
In Commercial Distribution

  • 00842768006661 ()
OPAB03

  • Coagulation factor VIII-associated antigen IVD, kit, nephelometry/turbidimetry

DImension Vista® Protein 2 Control H - 00842768006487

PROT2 CON H is an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of ASL, CRP and RF methods on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445937
In Commercial Distribution

  • 00842768006487 ()
  • 00842768019272 ()
KC787

  • Plasma protein IVD, control

DImension Vista® Protein 2 Control L - 00842768006470

PROT2 CON L is an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of ASL, CRP and RF methods on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445936
In Commercial Distribution

  • 00842768006470 ()
  • 00842768019289 ()
KC785

  • Plasma protein IVD, control

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 CRP Control H (high) - 00842768006432

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
10445930
In Commercial Distribution

  • 00842768006432 ()
  • 00842768019326 ()
KC757

  • C-reactive protein (CRP) IVD, control

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® Protein 1 Control H (high) - 00842768006357

PROT1 CON H is an assayed, high level ,intralaboratory, multi-analyte quality control for the assessment of precision and analytical bias on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445921
In Commercial Distribution

  • 00842768006357 ()
  • 00842768019401 ()
KC717

  • 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® Hemopexin Flex® reagent cartridge - 00842768006319

For the quantitative measurement of hemopexin in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445916
Not in Commercial Distribution

  • 00842768006319 ()
  • 00842768020254 ()
K7088

  • Haemopexin IVD, reagent

DImension Vista® Immunoglobulin G Subclass 4 Flex® Reagent Cartridge - 00842768006296

For the quantitative measurement of immunoglobulin G subclass 4 in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445914
In Commercial Distribution

  • 00842768006296 ()
  • 00842768020230 ()
K7083

  • 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

DImension Vista® Immunoglobulin G Subclass 1 Flex® reagent cartridge - 00842768006265

For the quantitative measurement of immunoglobulin G subclass 1 in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445911
In Commercial Distribution

  • 00842768006265 ()
  • 00842768020186 ()
K7080

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

Dade® Ci-Trol® Coagulation Control Level 3 - 00842768004070

For use as control in citrated coagulation systems
Siemens Healthcare Diagnostics Products GmbH
10445733
In Commercial Distribution

  • 00842768004070 ()
  • 00842768019456 ()
B4244-30

  • Multiple coagulation factor IVD, control
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