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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a selective and differential media for the detection of sorbitol-non-fermenting Escherichia coli serotype O157:H7 associated with hemorrhagic colitis. This medium is also referred to as "MacConkey Sorbitol Agar."
BIO-MED DIAGNOSTICS, INC.
1423
In Commercial Distribution

  • B08814234 ()
  • B08814230 ()
  • B08814232 ()
21-423-001

  • Sorbitol-MacConkey E. coli agar culture medium IVD
E. coli O2
PRO-LAB, INCORPORATED
PLA548
In Commercial Distribution

  • 00817978025481 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent
E. coli H7
PRO-LAB, INCORPORATED
PLA546
In Commercial Distribution

  • 00817978025467 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent
E. coli O157
PRO-LAB, INCORPORATED
PLA545
In Commercial Distribution

  • 00817978025450 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent
LAMINECTOMY E,KIT
Cardinal Health 200, LLC
PNOCDE36O
In Commercial Distribution

  • 50887488255246 ()
  • 10887488255248 ()
PNOCDE36O

  • Embolization implant kit
Lyphochek Allergen sIgE Control Panel A MiniPak (An assayed human serum allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000144
In Commercial Distribution

  • 00847661005759 ()
12000144

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control
Lyphochek Allergen sIgE Control Negative MiniPak (An assayed human based allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000143
In Commercial Distribution

  • 00847661005742 ()
12000143

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control
Lyphochek Allergen sIgE Control Panel A (An assayed human serum allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000142
In Commercial Distribution

  • 00847661005735 ()
12000142

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control
Lyphochek Allergen sIgE Control Negative (An assayed human based allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000141
In Commercial Distribution

  • 00847661005728 ()
12000141

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control
Harris Hematoxylin without Mercury
TRANSENE COMPANY, INC.
1
In Commercial Distribution

  • SO942852042008 ()

  • Total Volume: 1 Gallon
  • Total Volume: 1 Quart
  • Total Volume: 1 Pint
  • Total Volume: 8 Fluid Ounce
  • Total Volume: 4 Fluid Ounce


  • Haematoxylin and eosin (H&E) stain control IVD, kit
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