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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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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
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