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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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Bleach
PEARSON DENTAL SUPPLIES, INC.
N110450
In Commercial Distribution

  • D724N1104500 ()


  • Temporary dental crown/bridge resin
Shade A3
PEARSON DENTAL SUPPLIES, INC.
N110106
In Commercial Distribution

  • D724N1101061 ()


  • Temporary dental crown/bridge resin
Shade Bleach
PEARSON DENTAL SUPPLIES, INC.
N110101
In Commercial Distribution

  • D724N1101011 ()


  • Temporary dental crown/bridge resin
Amplichek II Level 3 MiniPak (A nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000578
In Commercial Distribution

  • 00847661005995 ()
12000578

  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
  • Clostridium difficile nucleic acid IVD, control
  • MRSA nucleic acid IVD, control
Amplichek II Level 2 MiniPak (A nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000577
In Commercial Distribution

  • 00847661005988 ()
12000577

  • MRSA nucleic acid IVD, control
  • Clostridium difficile nucleic acid IVD, control
  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
Amplichek II Level 1 MiniPak (A nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000576
In Commercial Distribution

  • 00847661005971 ()
12000576

  • Clostridium difficile nucleic acid IVD, control
  • MRSA nucleic acid IVD, control
  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
Amplichek II Negative MiniPak (A nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000575
In Commercial Distribution

  • 00847661005964 ()
12000575

  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
  • Clostridium difficile nucleic acid IVD, control
  • MRSA nucleic acid IVD, control
Amplichek II Level 3 (A nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000204
In Commercial Distribution

  • 00847661005957 ()
12000204

  • MRSA nucleic acid IVD, control
  • Clostridium difficile nucleic acid IVD, control
  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
Amplichek II Level 2 (A nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000203
In Commercial Distribution

  • 00847661005940 ()
12000203

  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
  • Clostridium difficile nucleic acid IVD, control
  • MRSA nucleic acid IVD, control
Amplichek II Level 1 (A nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000202
In Commercial Distribution

  • 00847661005933 ()
12000202

  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
  • Clostridium difficile nucleic acid IVD, control
  • MRSA nucleic acid IVD, control
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