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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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The Premier EHEC test is a rapid in vitro microwell EIA for the detection of Shiga Toxins I and II (Verotoxins) in stool specimens, broth cultures, from individual colonies or colony sweeps of agar plates. The Premier EHEC test is intended for use as an aid in the diagnosis of enterohemorrhagic E. coli (EHEC) infections.
MERIDIAN BIOSCIENCE, INC.
608096
In Commercial Distribution

  • 00840733101724 ()
608096

  • Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA)
The ImmunoCard STAT E. coli O157 Plus is a rapid test for the detection of antigens from Shiga toxin-production E. coli O157 as an aid in the diagnosis of E. coli O157:H7 infection. The test can be used to directly test stool specimens, stool in modified Cary-Blair medium or confirmatory stool cultures grown in MacConkey broth of sorbitol MacConkey (SMAC) plates. In the US, ImmunoCard STAT E. coli O157 Plus is not intended for point-of-care use. This device is intended for moderately complex laboratories. In Canada, this device is not intended for point-of-care use.
MERIDIAN BIOSCIENCE, INC.
750530
In Commercial Distribution

  • 00840733101816 ()
750530

  • Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA)
"720-480 anti-Cardiolipin Screen"
DIAMEDIX CORPORATION
720-480
In Commercial Distribution

  • 00817273020280 ()


  • Anti-E [RH0003] antibody screen IVD, control
E. coliPRO™ O157 Latex Kit, rapid latex agglutination test for E. coli O157, 50 tests A rapid latex agglutination test kit for the identification of the E. coli O157 serotype. So sensitive that it requires only one single colony. Uses proprietary antibodies that eliminate the possibility of cross-reactions with Escherichia hermanii and other sorbitol-negative Escherichia species. Contains both positive and negative controls. Includes reaction cards and mixing sticks Each kit contains: E. coliPRO™ O157 Latex Reagent 1 dropper vial/kit E. coliPRO™ O157 Positive Control Suspension 1 dropper vial/kit E. coliPRO™ O157 Negative Control Latex Reagent 1 dropper vial/kit Latex Test Cards 20 cards/kit Mixing Sticks 75 sticks/kit
HARDY DIAGNOSTICS
PL070HD
In Commercial Distribution

  • 00819398027953 ()
PL070HD

  • Escherichia coli antibody IVD, reagent
Native Ole e 1-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10370467
In Commercial Distribution

  • 00630414982915 ()
A482L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Mouse Urine -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385657
In Commercial Distribution

  • 00630414996615 ()
E72L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Rat Urine Proteins -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385659
In Commercial Distribution

  • 00630414996608 ()
E74L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Rat Serum Proteins -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385660
In Commercial Distribution

  • 00630414996592 ()
E75L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Mouse Serum Proteins -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385661
In Commercial Distribution

  • 00630414996585 ()
E76L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Pigeon Droppings -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385663
In Commercial Distribution

  • 00630414996578 ()
E7L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
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