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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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CRYOcheck Chromogenic Factor IX is for clinical laboratory use in the quantitative determination of factor IX activity in 3.2% citrated human plasma. It is intended to be used in identifying factor IX deficiency and as an aid in the management of hemophilia B in individuals aged 2 years and older. For in vitro diagnostic use
Precision Biologic Inc
CCCF09
In Commercial Distribution

  • 00843876000565 ()
CCCF09

  • Coagulation factor IX IVD, kit, chromogenic
No Description
DIAGNOSTICA STAGO
00724
In Commercial Distribution

  • 13607450007241 ()
  • 03607450007244 ()


  • Coagulation factor IX IVD, kit, clotting
Factor IX immunodepleted 10 x 1 ml
R 2 DIAGNOSTICS, INC.
69-201
In Commercial Distribution

  • 10859394006160 ()
  • 00859394006163 ()
69-201

  • Coagulation factor IX IVD, kit, clotting
HemosIL Factor IX Deficient Plasma (10 X 1 mL)
INSTRUMENTATION LABORATORY COMPANY
00020011900
In Commercial Distribution

  • 08426950478553 ()
  • 18426950478550 ()
00020011900

  • Coagulation factor IX IVD, kit, clotting
HemosIL Chromogenic Factor IX
INSTRUMENTATION LABORATORY COMPANY
0020012900
In Commercial Distribution

  • 00195226001129 ()
0020012900

  • Coagulation factor IX IVD, kit, chromogenic
No Description
TCOAG IRELAND LIMITED
T1509
In Commercial Distribution

  • 15391521420418 ()
  • 05391521420411 ()


  • Coagulation factor IX IVD, kit, clotting
No Description
Roche Molecular Systems, Inc.
09040773190
In Commercial Distribution

  • 00875197006476 ()
09040773190

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
No Description
Roche Diagnostics GmbH
1.0
In Commercial Distribution

  • 00875197004748 ()
06998887190

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
Amplichek I MiniPak (An assayed nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000531
In Commercial Distribution

  • 03610520530092 ()
12000531

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
Amplichek I Level 3 (An assayed nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000530
In Commercial Distribution

  • 03610520530085 ()
12000530

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
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