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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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Mast Assure Antisera - 15060392377021

M12023 - Escherichia coli Antiserum O126 - 2ml
MAST GROUP LIMITED
M12023
In Commercial Distribution

  • 15060392377021 ()
M12023

  • Escherichia coli antigen IVD, kit, agglutination

Mast Assure Antisera - 15060392377014

M12022 - Escherichia coli Antiserum O125 - 1 pack of 2ml
MAST GROUP LIMITED
M12022
In Commercial Distribution

  • 15060392377014 ()
M12022

  • Escherichia coli antigen IVD, kit, agglutination

Mast Assure Antisera - 15060392377007

M12021 - Escherichia coli Antiserum O55 - 1 pack of 2ml
MAST GROUP LIMITED
M12021
In Commercial Distribution

  • 15060392377007 ()
M12021

  • Escherichia coli antigen IVD, kit, agglutination

Mast Assure Antisera - 15060392376314

M14270 - Escherichia coli Polyvalent O Antiserum - POLY 3 Factors O86, O114, O125, O127, O128 - 2ml
MAST GROUP LIMITED
M14270
In Commercial Distribution

  • 15060392376314 ()
M14270

  • Escherichia coli antigen IVD, kit, agglutination

Mast Assure Antisera - 15060392376307

M14263 - Escherichia coli Polyvalent O Antiserum - POLY 2 Factors O26, O55, O111, 0119, O126 - 2ml
MAST GROUP LIMITED
M14263
In Commercial Distribution

  • 15060392376307 ()
M14263

  • Escherichia coli antigen IVD, kit, agglutination

Mast Assure - 15060392376291

Escherichia coli Monovalent O Antiserum - Factor O157 - 2ml
MAST GROUP LIMITED
M12030
In Commercial Distribution

  • 15060392376291 ()
M12030

  • Escherichia coli antigen IVD, kit, agglutination

Mast Assure Antisera - 15060392376284

M12018 - Escherichia coli Monovalent O Antiserum - Factor O127a - 2ml
MAST GROUP LIMITED
M12018
In Commercial Distribution

  • 15060392376284 ()
M12018

  • Escherichia coli antigen IVD, kit, agglutination

AIA-PACK IgEII Sample Diluting Solution - 04560189211087

No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211087 ()


  • Total immunoglobulin E (IgE total) IVD, reagent

ImmunoCard STAT E. coli O157 Plus - 00840733101816

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)

PREMIER EHEC - 00840733101724

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)
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