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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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DImension Vista® Homocysteine Flex® reagent cartridge - 00842768006128

For the quantitative measurement of total homocysteine in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445897
In Commercial Distribution

  • 00842768006128 ()
  • 00842768020032 ()
K7044

  • Homocysteine IVD, reagent

DImension Vista® Haptoglobin Flex® reagent cartridge - 00842768006111

For the quantitative measurement of haptoglobin in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445896
In Commercial Distribution

  • 00842768006111 ()
  • 00842768020025 ()
K7042

  • Haptoglobin IVD, kit, nephelometry/turbidimetry

DImension Vista® Cystatin C Flex® reagent cartridge - 00842768006104

For the quantitative measurement of cystatin C in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445895
In Commercial Distribution

  • 00842768006104 ()
  • 00842768020001 ()
K7040

  • Cystatin C IVD, kit, nephelometry/turbidimetry

DImension Vista® sALB Flex® reagent cartridgeSpecialty Albumin - 00842768006098

For the quantitative measurement of albumin in human serum and plasma and cerebrospinal fluid (CSF) on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445894
In Commercial Distribution

  • 00842768006098 ()
  • 00842768019999 ()
K7034

  • Albumin IVD, kit, nephelometry/turbidimetry

Dimension Vista® C-Reactive Protein Flex® reagent cartridge - 00842768006081

For the quantitative measurement of C-reactive protein in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445893
In Commercial Distribution

  • 00842768006081 ()
  • 00842768019982 ()
K7032

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

Dimension Vista® Ceruloplasmin Flex® reagent cartridge - 00842768006074

For the quantitative measurement of ceruloplasmin in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445892
In Commercial Distribution

  • 00842768006074 ()
  • 00842768019975 ()
K7030

  • Ceruloplasmin IVD, kit, nephelometry/turbidimetry

Dimension Vista® C4 Complement Flex® reagent cartridge - 00842768006067

For the quantitative measurement of C4 complement in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445891
In Commercial Distribution

  • 00842768006067 ()
  • 00842768019968 ()
K7028

  • Complement components C4/C4c IVD, kit, nephelometry/turbidimetry

Dimension Vista® C3 Complement Flex® reagent cartridge - 00842768006050

For the quantitative measurement of C3 complement in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445890
In Commercial Distribution

  • 00842768006050 ()
  • 00842768019951 ()
K7026

  • Complement components C3/C3c IVD, kit, nephelometry/turbidimetry

Dimension Vista® ß2-Microglobulin Flex® reagent cartridge - 00842768006043

For the quantitative measurement of ß2-microglobulin in human serum, plasma and urine on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445889
In Commercial Distribution

  • 00842768006043 ()
K7024

  • Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry

Dimension Vista®Antistreptolysin O Flex® reagent cartridge - 00842768006036

For the quantitative measurement of antistreptolysin O in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445888
In Commercial Distribution

  • 00842768006036 ()
  • 00842768019944 ()
K7022

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

Dimension Vista®Apolipoprotein B Flex® reagent cartridge - 00842768006029

For the quantitative measurement of apolipoprotein B in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445887
In Commercial Distribution

  • 00842768006029 ()
  • 00842768019906 ()
K7020

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry

Dimension Vista® Apolipoprotein AI Flex® reagent cartridge - 00842768006012

For the quantitative measurement of apolipoprotein A-I in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445886
In Commercial Distribution

  • 00842768006012 ()
  • 00842768019890 ()
K7018

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

Dimension Vista®a1-Antitrypsin Flex® reagent cartridge - 00842768005992

For the quantitative measurement of a1-antitrypsin in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445884
In Commercial Distribution

  • 00842768005992 ()
  • 00842768019876 ()
K7014

  • Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry

Dimension Vista® a1-Acid Glycoprotein Flex® reagent cartridge - 00842768005985

For the quantitative measurement of a1-acid glycoprotein (Orosomucoid) in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445883
In Commercial Distribution

  • 00842768005985 ()
  • 00842768019869 ()
K7012

  • Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry

Dimension Vista® a1-Microglobulin Flex® reagent cartridge - 00842768005978

For the quantitative measurement of a1-microglobulin in human urine on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445882
Not in Commercial Distribution

  • 00842768005978 ()
  • 00842768019852 ()
K7010

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

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

Dade® Ci-Trol® Coagulation Control Level 2 - 00842768004063

For use as control in citrated coagulation systems
Siemens Healthcare Diagnostics Products GmbH
10445732
In Commercial Distribution

  • 00842768004063 ()
  • 00842768019463 ()
B4244-20

  • Multiple coagulation factor IVD, control

Dade® Ci-Trol® Coagulation Control Level 1 - 00842768004056

For use as control in citrated coagulation systems
Siemens Healthcare Diagnostics Products GmbH
10445731
In Commercial Distribution

  • 00842768004056 ()
  • 00842768019470 ()
B4244-10

  • Multiple coagulation factor IVD, control

Dade® Hepzyme® - 00842768004049

Heparin neutralizer in plasma to rule out heparin contamination in coagulation testing
Siemens Healthcare Diagnostics Products GmbH
10445730
In Commercial Distribution

  • 00842768004049 ()
  • 00842768019487 ()
B4240-10

  • Coagulation inhibitory substance neutralization IVD, reagent

Factor VIII Chromogenic Assay - 00842768004032

Determination of Factor VIII (antihemophilic factor) activity in human plasma
Siemens Healthcare Diagnostics Products GmbH
10445729
In Commercial Distribution

  • 00842768004032 ()
B4238-40

  • Coagulation factor VIII IVD, kit, chromogenic

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
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