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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/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

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

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 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® 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
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