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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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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

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

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, K-type - 00842768012686

Quantitative determination of Ig light chains, type kappa in human serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446595
In Commercial Distribution

  • 00842768012686 ()
OWHG13

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