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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 Antiserum to Human a2-Macroglobulin - 00842768029967

Quantitative determination of a2-macroglobulin in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10469773
In Commercial Distribution

  • 00842768029967 ()
OSAM21

  • Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetry

IMMULITE® Probe Cleaning Kit - 00842768028441

For use in daily maintenance of the IMMULITE® and IMMULITE® 1000 systems
Siemens Healthcare Diagnostics Products GmbH
10385332
In Commercial Distribution

  • 00842768028441 ()
LKPM

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

IMMULITE 2000/XPi Probe Cleaning Kit - 00842768028434

For use in daily maintenance of the IMMULITE® 2000 and IMMULITE® 2500 Analyzers
Siemens Healthcare Diagnostics Products GmbH
10385229
In Commercial Distribution

  • 00842768028434 ()
L2KPM

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

IMMULITE 2000/XPi Probe Wash Module - 00842768028427

For use in the routine operation of the IMMULITE® 2000 and IMMULITE® 2500 Analyzers
Siemens Healthcare Diagnostics Products GmbH
10385231
In Commercial Distribution

  • 00842768028427 ()
  • 00842768019708 ()
L2PWSM

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

IMMULITE® Probe Wash Module - 00842768028410

For use in the routine operation of the IMMULITE® and IMMULITE® 1000 Analyzers
Siemens Healthcare Diagnostics Products GmbH
10385393
In Commercial Distribution

  • 00842768028410 ()
  • 00842768019760 ()
LPWS2

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

INNOVANCE VWF Ac - 00842768028014

For the quantitative determination of von Willenbrand factor (VWF) GPIb-binding activity in human sodium citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10487040
In Commercial Distribution

  • 00842768028014 ()
OPHL035

  • von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry

INNOVANCE® D-Dimer Sample Diluent - 00842768027611

For use in conjunction with INNOVANCE D-Dimer to dilute samples
Siemens Healthcare Diagnostics Products GmbH
10487039
In Commercial Distribution

  • 00842768027611 ()
  • 00842768019265 ()
OPBR03

  • Buffered sample diluent IVD

INNOVANCE® Antithrombin - 00842768027024

Chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10487304
In Commercial Distribution

  • 00842768027024 ()
OPFH07

  • Antithrombin III (ATIII) IVD, kit, chromogenic

INNOVANCE® Antithrombin - 00842768027017

Chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10487303
In Commercial Distribution

  • 00842768027017 ()
OPFH09

  • Antithrombin III (ATIII) IVD, kit, chromogenic

Standard Human Plasma - 00842768026812

Standard Human Plasma for the calibration of coagulation and fibrinolysis tests
Siemens Healthcare Diagnostics Products GmbH
10487098
In Commercial Distribution

  • 00842768026812 ()
  • 00842768018893 ()
ORKL19

  • Multiple coagulation factor IVD, calibrator

BFT II Analyzer - 00842768024887

The BFT II Analyzer is a semi-automated device intended for use to determine PT, APTT and Fibrinogen
Siemens Healthcare Diagnostics Products GmbH
10458677
In Commercial Distribution

  • 00842768024887 ()
OVKF032

  • Coagulation analyser IVD, laboratory, semi-automated

PFA-100® System - 00842768024870

To aid in the detection of platelet dysfunction in citrated human whole blood
Siemens Healthcare Diagnostics Products GmbH
10444868
In Commercial Distribution

  • 00842768024870 ()
B4170-00

  • Platelet aggregation analyser IVD

Dimension Vista® PROT3 CON - 00842768024498

PROT3 CON is an assayed, intralaboratory, multi-analyte quality control for the assessment of precision and analytical bias on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10465668
In Commercial Distribution

  • 00842768024498 ()
  • 00842768019302 ()
KC775U

  • Plasma protein IVD, control

Dimension Vista® PROT1 CAL - 00842768024443

PROT1 CAL is a multi-analyte calibrator for the use on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10465664
In Commercial Distribution

  • 00842768024443 ()
  • 00842768019449 ()
KC710U

  • Plasma protein IVD, calibrator

Dimension Vista® Flex® reagent cartridge LAMBDA - 00842768024436

For the quantitative measurement of immunoglobulin light chains, type lambda in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10465672
In Commercial Distribution

  • 00842768024436 ()
  • 00842768020063 ()
K7051

  • Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry

Dimension Vista® Flex® reagent cartridge KAPPA - 00842768024429

For the quantitative measurement of immunoglobulin light chains, type kappa in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10465671
In Commercial Distribution

  • 00842768024429 ()
  • 00842768020056 ()
K7049

  • Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry

Dimension Vista® Flex® reagent cartridge A2MAC - 00842768024412

For the quantitative measurement of a2-macroglobulin in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10465670
Not in Commercial Distribution

  • 00842768024412 ()
  • 00842768019883 ()
K7017

  • Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetry

INNOVANCE® D-Dimer Controls - 00842768023668

INNOVANCE® D-Dimer Control 1 and Control 2 are assayed, normal and pathological level, intralaboratory quality controls for assessment of precision and analytical bias in the quantitative determination of D-dimer on Siemens and Sysmex® Systems
Siemens Healthcare Diagnostics Products GmbH
10446006
In Commercial Distribution

  • 00842768023668 ()
OPDY09

  • D-dimer IVD, control

INNOVANCE® D-Dimer - 00842768022821

For the quantitative determination of cross-linked fibrin degradation products (D-dimers) in human plasma on Siemens Sysmex® Coagulation Systems
Siemens Healthcare Diagnostics Products GmbH
10445982
In Commercial Distribution

  • 00842768022821 ()
OPBP11

  • D-dimer IVD, kit, agglutination

INNOVANCE® D-Dimer - 00842768022814

For the quantitative determination of cross-linked fibrin degradation products (D-dimers) in human plasma on Siemens Sysmex® Coagulation Systems
Siemens Healthcare Diagnostics Products GmbH
10445981
In Commercial Distribution

  • 00842768022814 ()
OPBP09

  • D-dimer IVD, kit, agglutination

N/T Protein Control PY - 00842768021138

Assayed control for Fibrinogen, Antithrombin III, Plasminogen and C1 Inhibitor assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446656
In Commercial Distribution

  • 00842768021138 ()
  • 00842768018565 ()
OWSY15

  • Plasma protein IVD, control

Apolipoprotein Control Serum CHD - 00842768021121

Assayed control for apolipoprotein A-I and B and CRP assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446469
In Commercial Distribution

  • 00842768021121 ()
  • 00842768018596 ()
OUPH09

  • Plasma protein IVD, control

N Protein Standard PY - 00842768021114

Calibration of Fibrinogen, Antithrombin III, Plasminogen and C1 Inhibitor assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446450
In Commercial Distribution

  • 00842768021114 ()
  • 00842768018732 ()
OUID15

  • Plasma protein IVD, calibrator

N Latex CDT Kit - 00842768018534

Quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10445997
In Commercial Distribution

  • 00842768018534 ()
OPCS05

  • Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry

Multifibren® U - 00842768017872

Quantitative determination of fibrinogen in plasma
Siemens Healthcare Diagnostics Products GmbH
10446691
In Commercial Distribution

  • 00842768017872 ()
  • 00842768018503 ()
OWZG23

  • Fibrinogen assay (factor I) IVD, reagent

Multifibren® U - 00842768017865

Quantitative determination of fibrinogen in plasma
Siemens Healthcare Diagnostics Products GmbH
10446689
In Commercial Distribution

  • 00842768017865 ()
  • 00842768018541 ()
OWZG19

  • Fibrinogen assay (factor I) IVD, reagent

INNOVANCE Heparin - 00842768017438

For the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH)
Siemens Healthcare Diagnostics Products GmbH
10873535
In Commercial Distribution

  • 00842768017438 ()
OPOA05

  • Heparin anti-Xa IVD, kit, chromogenic

INNOVANCE Heparin LMW Control 1 - 00842768017100

For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873534
In Commercial Distribution

  • 00842768017100 ()
  • 00630414229539 ()
OPOE05

  • Heparin anti-Xa IVD, control

INNOVANCE Heparin LMW Control 2 - 00842768017094

For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873533
In Commercial Distribution

  • 00842768017094 ()
  • 00630414229546 ()
OPOF05

  • Heparin anti-Xa IVD, control

INNOVANCE Heparin UF Control 2 - 00842768017087

For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873532
In Commercial Distribution

  • 00842768017087 ()
  • 00630414229522 ()
OPOD05

  • Heparin anti-Xa IVD, control

INNOVANCE Heparin UF Control 1 - 00842768017070

For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873531
In Commercial Distribution

  • 00842768017070 ()
  • 00630414229515 ()
OPOC05

  • Heparin anti-Xa IVD, control

INNOVANCE Heparin Calibrator - 00842768017063

For calibration of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873530
In Commercial Distribution

  • 00842768017063 ()
OPOB05

  • Heparin anti-Xa IVD, calibrator

N/T Protein Control SL/M - 00842768016134

N/T Protein Control SL/M is a medium level, multi-analyte control for use as accuracy and precision control in the determination of human serum proteins by immunonephelometry with the BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446085
In Commercial Distribution

  • 00842768016134 ()
  • 00842768019036 ()
OQIO19

  • Plasma protein IVD, control

N/T Protein Control SL/L - 00842768016127

N/T Protein Control SL/L is a low level, multi-analyte control for use as accuracy and precision control in the determination of human serum proteins by immunonephelometry with the BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446079
In Commercial Distribution

  • 00842768016127 ()
  • 00842768019043 ()
OQIN19

  • Plasma protein IVD, control

N/T Protein Control SL/H - 00842768016110

N/T Protein Control SL/H is a high level, multi-analyte control for use as accuracy and precision control in the determination of human serum proteins by immunonephelometry with the BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446089
In Commercial Distribution

  • 00842768016110 ()
  • 00842768019029 ()
OQIP19

  • Plasma protein IVD, control

BCS® System Cuvette Rotors - 00842768014444

The BCS Cuvette Rotor is part of the BCS-XP system.
Siemens Healthcare Diagnostics Products GmbH
10446524
In Commercial Distribution

  • 00842768014444 ()
  • 00842768024603 ()
OVIP15

  • Coagulation analyser IVD, laboratory

Calcium Chloride Solution - 00842768014222

Supplementary Reagent for coagulation tests
Siemens Healthcare Diagnostics Products GmbH
10446232
In Commercial Distribution

  • 00842768014222 ()
  • 00842768018916 ()
ORHO37

  • Calcium chloride coagulation reagent IVD

Berichrom® Antithrombin III (A) - 00842768013478

Determination of the functional activity of antithrombin III (AT III) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10446673
In Commercial Distribution

  • 00842768013478 ()
OWWR17

  • Antithrombin III (ATIII) IVD, kit, chromogenic

Berichrom® Antithrombin III (A) - 00842768013461

Determination of the functional activity of antithrombin III (AT III) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10446672
In Commercial Distribution

  • 00842768013461 ()
OWWR15

  • Antithrombin III (ATIII) IVD, kit, chromogenic

N Latex ADNase B - 00842768013317

Quantitative determination of ADNase B in human serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446658
In Commercial Distribution

  • 00842768013317 ()
OWTI11

  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, reagent

BC Thrombin Reagent - 00842768013102

Quantitative determination of thrombin time in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10446636
In Commercial Distribution

  • 00842768013102 ()
OWNA11

  • Thrombin time (TT) IVD, kit, clotting

Enzygnost® TAT micro - 00842768013065

Quantitative determination of thrombin/antithrombin III complex (TAT) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10446632
In Commercial Distribution

  • 00842768013065 ()
OWMG15

  • Coagulation factor VIII IVD, kit, chromogenic

Berichrom® Heparin - 00842768012945

Determination of heparin activity in plasma and for the monitoring of heparin therapy
Siemens Healthcare Diagnostics Products GmbH
10446620
Not in Commercial Distribution

  • 00842768012945 ()
OWLD11

  • Heparin anti-Xa IVD, kit, chromogenic

N a1-Microglobulin Kit - 00842768012938

Quantitative determination of a1-microglobulin in human urine on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446619
In Commercial Distribution

  • 00842768012938 ()
OWLA11

  • Alpha-1-microglobulin IVD, kit, nephelometry/turbidimetry

N Latex Myoglobin - 00842768012808

Quantitative determination of myoglobin in human serun and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446607
In Commercial Distribution

  • 00842768012808 ()
OWIA11

  • Myoglobin IVD, kit, nephelometry/turbidimetry

RapiTex® CRP - 00842768012778

Qualitative detection or semi-quantitative determination of C-reactive protein (CRP) in human serum
Siemens Healthcare Diagnostics Products GmbH
10446604
In Commercial Distribution

  • 00842768012778 ()
OWHU21

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

RapiTex® RF - 00842768012754

Qualitative detection or semi-quantitative determination of rheumatoid factors (RF) in human serum
Siemens Healthcare Diagnostics Products GmbH
10446602
In Commercial Distribution

  • 00842768012754 ()
OWHS21

  • Rheumatoid factor IVD, kit, agglutination

RapiTex® ASL - 00842768012730

Qualitative detection or semi-quantitative determination of anti-streptolysin O (ASL) in human serum
Siemens Healthcare Diagnostics Products GmbH
10446600
Not in Commercial Distribution

  • 00842768012730 ()
OWHP21

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

Test Thrombin Reagent - 00842768012716

Determination of thrombin time in human plasma
Siemens Healthcare Diagnostics Products GmbH
10446598
In Commercial Distribution

  • 00842768012716 ()
OWHM13

  • Thrombin time (TT) IVD, kit, clotting

N Antiserum to Human-Ig/L-chain, L-type - 00842768012709

Quantitative determination of Ig light chains, type lambda in human serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446597
In Commercial Distribution

  • 00842768012709 ()
OWHH13

  • Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry
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