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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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No Description
Roche Molecular Systems, Inc.
04626303190
In Commercial Distribution

  • 00875197001754 ()
04626303190

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
No Description
Roche Molecular Systems, Inc.
03302555018
In Commercial Distribution

  • 00875197001051 ()
03302555018

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
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
06999069190
In Commercial Distribution

  • 00875197004847 ()
06999069190

  • 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
No Description
Roche Molecular Systems, Inc.
2.0
In Commercial Distribution

  • 00875197004014 ()
05965390190

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
Toxi-Titer Plate, 48 Wells
MARDX DIAGNOSTICS, INC.
B1029-70D
In Commercial Distribution

  • 05391516747998 ()
B1029-70D

  • Clostridium difficile toxin A/B antigen IVD, reagent
Bartels® Cytotoxicity Assay for Clostridium difficile Toxin Product B1029-70, Store Toxi-Titer Plate @ 35-37 °C, Store Reagents @ 2-8 °C, 48 Tests
MARDX DIAGNOSTICS, INC.
B1029-70
In Commercial Distribution

  • 05391516747950 ()
B1029-70

  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
No Description
DIAGNOSTICA STAGO
00943
In Commercial Distribution

  • 03607450009439 ()


  • Coagulation factor IX IVD, kit, enzyme immunoassay (EIA)
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
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