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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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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
Amplichek II Negative (A nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000201
In Commercial Distribution

  • 00847661005926 ()
12000201

  • Clostridium difficile nucleic acid IVD, control
  • MRSA nucleic acid IVD, control
  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
Hysteroscopy System indicated for both Hysteroscopy and Cystoscopy to permit direct viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
UVISION 360, INC.
LumDTX-A
In Commercial Distribution

  • 00853277008046 ()
20030

  • Flexible video cystoscope, reusable
  • Endoscope sheath, single-use
  • Flexible fibreoptic hysteroscope
Airo™ CPAP Mask Liners - Box of 25 - Large
Athfar 828 Inc
AL-25
In Commercial Distribution

  • 00850054813343 ()
  • 00850054813381 ()


  • General-purpose medical fibre padding
Airo™ CPAP Mask Liners - Box of 25 - Small
Athfar 828 Inc
AS-25
In Commercial Distribution

  • 00850054813350 ()
  • 00850054813374 ()


  • General-purpose medical fibre padding
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