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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® Cluster® Platelet Aggregation Reagents - 00842768003998

For use in platelet aggregometry studies
Siemens Healthcare Diagnostics Products GmbH
10445725
In Commercial Distribution

  • 00842768003998 ()
B4236-1

  • Platelet aggregation study IVD, kit, nephelometry/turbidimetry

Dade® Owren's Veronal Buffer - 00842768003981

Dilution buffer for coagulation testing
Siemens Healthcare Diagnostics Products GmbH
10445724
In Commercial Distribution

  • 00842768003981 ()
  • 00842768019494 ()
B4234-25

  • Buffered sample diluent IVD

Dade® DIMERTEST® Latex Beads - 00842768003974

For use with DIMERTEST® Latex kit for the rapid qualitative or semiquantitative evaluation of circulating derivatives of cross-linked fibrin degradation products (XL-FDP) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10445723
Not in Commercial Distribution

  • 00842768003974 ()
B4233-61L

  • D-dimer IVD, reagent

Dade® DIMERTEST® Latex Assay - 00842768003967

The DIMERTEST® Latex Assay is intended for the rapid qualitative or semiquantitative evaluation of circulating derivatives of cross-linked fibrin degradation products (XL-FDP) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10445722
Not in Commercial Distribution

  • 00842768003967 ()
B4233-60

  • D-dimer IVD, kit, agglutination

Dade® Thrombin Reagent - 00842768003950

Determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies
Siemens Healthcare Diagnostics Products GmbH
10445721
In Commercial Distribution

  • 00842768003950 ()
  • 00842768019500 ()
B4233-27

  • Fibrinogen assay (factor I) IVD, reagent

Dade® Thrombin Reagent - 00842768003943

Determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies
Siemens Healthcare Diagnostics Products GmbH
10445720
In Commercial Distribution

  • 00842768003943 ()
  • 00842768019517 ()
B4233-25

  • Fibrinogen assay (factor I) IVD, reagent

Dade® Data-Fi® Abnormal Fibrinogen Control - 00842768003936

Assessment of accuracy and precision of Dade® Fibrinogen Determination Reagents in the low range
Siemens Healthcare Diagnostics Products GmbH
10445719
In Commercial Distribution

  • 00842768003936 ()
  • 00842768019524 ()
B4233-22

  • Fibrinogen assay (factor I) IVD, control

Dade® Fibrinogen Determination Reagents - 00842768003929

Quantitative determination of fibrinogen in human plasma
Siemens Healthcare Diagnostics Products GmbH
10445718
Not in Commercial Distribution

  • 00842768003929 ()
B4233-15SY

  • Fibrinogen assay (factor I) IVD, kit, clotting

INNOVANCE Free PS Ag - 00842768039522

For the quantitative determination of free protein S antigen in human plasma collected from venous blood samplesin 3.2 % sodium citrate tubes on the BCS XP System, the SYSMEX CS-2500 analyzer and the SYSMEX CS-5100 analyzer.
Siemens Healthcare Diagnostics Products GmbH
10873458
In Commercial Distribution

  • 00842768039522 ()
OPGL07

  • Protein S IVD, kit, nephelometry/turbidimetry

Dade® CA System Buffer - 00842768039416

For coagulation tests and as a rinsing solution for the sample needles of the Sysmex® CA Systems
Siemens Healthcare Diagnostics Products GmbH
10873440
In Commercial Distribution

  • 00842768039416 ()
  • 00842768019845 ()
B4265-37

  • Buffered sample diluent IVD

BC von Willebrand Reagent - 00842768038211

Determination of ristocetin co-factor activity of von Willebrand factor in human plasma through platelet agglutination
Siemens Healthcare Diagnostics Products GmbH
10714565
In Commercial Distribution

  • 00842768038211 ()
  • 00842768018800 ()
OUBD39

  • von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent

N Antiserum to Human Albumin - 00842768038020

Quantitative determination of albumin in human serum, plasma, urine and CSF on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10714509
In Commercial Distribution

  • 00842768038020 ()
OSAL25

  • Albumin IVD, kit, nephelometry/turbidimetry

N Antiserum to Human Albumin - 00842768038013

Quantitative determination of albumin in human serum, plasma, urine and CSF on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10714508
In Commercial Distribution

  • 00842768038013 ()
OSAL23

  • Albumin IVD, kit, nephelometry/turbidimetry

INNOVANCE Antithrombin - 00842768037146

Chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10709521
In Commercial Distribution

  • 00842768037146 ()
OPFH11

  • Antithrombin III (ATIII) IVD, kit, chromogenic

Factor V Leiden - 00842768033520

Russell Viper Venom-based test for screening of resistance to Activated Protein C (APC) in plasma from individuals with the Factor V (Leiden) defect
Siemens Healthcare Diagnostics Products GmbH
10459420
In Commercial Distribution

  • 00842768033520 ()
OQYI11

  • Activated protein C resistance ratio (APCR) IVD, kit, clotting

N FLC Control SL2 - 00842768031465

Assayed accuracy and precision controls in the determination of free light chains (FLC) type kappa and type lambda on Siemens analyzers
Siemens Healthcare Diagnostics Products GmbH
10482442
In Commercial Distribution

  • 00842768031465 ()
  • 04056869221960 ()
OPJF03

  • Kappa/lambda light chain immunoglobulin IVD, control

N FLC Control SL1 - 00842768031458

Assayed accuracy and precision controls in the determination of free light chains (FLC) type kappa and type lambda on Siemens analyzers
Siemens Healthcare Diagnostics Products GmbH
10482441
In Commercial Distribution

  • 00842768031458 ()
  • 04056869221953 ()
OPJE03

  • Kappa/lambda light chain immunoglobulin IVD, control

N FLC Standard SL - 00842768031441

Establishment of reference curves for the determination of free light chains (FLC) type kappa and type lambda on Siemens analyzers
Siemens Healthcare Diagnostics Products GmbH
10482440
In Commercial Distribution

  • 00842768031441 ()
  • 04056869221946 ()
OPJD03

  • Kappa/lambda light chain immunoglobulin IVD, calibrator

N FLC Supplementary Reagent - 00842768031434

Quantitative determination of free light chains (FLC) type kappa and type lambda in human serum and EDTA-plasma on Siemens analyzers
Siemens Healthcare Diagnostics Products GmbH
10482439
In Commercial Distribution

  • 00842768031434 ()
OPJC03

  • Kappa/lambda light chain immunoglobulin IVD, reagent

N Diluent - 00842768030239

Solution for preparing dilutions for immunochemical determinations with the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10469513
In Commercial Distribution

  • 00842768030239 ()
  • 00842768020261 ()
OUMT05

  • Buffered sample diluent IVD

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
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