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

  • 15060392377021 ()
M12023

  • Escherichia coli antigen IVD, kit, agglutination
M12022 - Escherichia coli Antiserum O125 - 1 pack of 2ml
MAST GROUP LIMITED
M12022
In Commercial Distribution

  • 15060392377014 ()
M12022

  • Escherichia coli antigen IVD, kit, agglutination
M12021 - Escherichia coli Antiserum O55 - 1 pack of 2ml
MAST GROUP LIMITED
M12021
In Commercial Distribution

  • 15060392377007 ()
M12021

  • Escherichia coli antigen IVD, kit, agglutination
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
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
Escherichia coli Monovalent O Antiserum - Factor O157 - 2ml
MAST GROUP LIMITED
M12030
In Commercial Distribution

  • 15060392376291 ()
M12030

  • Escherichia coli antigen IVD, kit, agglutination
M12018 - Escherichia coli Monovalent O Antiserum - Factor O127a - 2ml
MAST GROUP LIMITED
M12018
In Commercial Distribution

  • 15060392376284 ()
M12018

  • Escherichia coli antigen IVD, kit, agglutination
The SHIGA TOXIN CHEK test is an enzyme immunoassay for the simultaneous qualitative detection of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test. It is intended for use with human fecal samples from patients with gastrointestinal symptoms to aid in the diagnosis of disease caused by Shiga Toxin producing Escherichia coli (STEC). It may be used directly with human fecal specimens, or broth or plate cultures derived from fecal specimens. The test results should be considered in conjunction with the patient history.
TECHLAB, INC.
T30696
In Commercial Distribution

  • 00857031002417 ()


  • Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA)
The SHIGA TOXIN QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the simultaneous qualitative detection and differentiation of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test device. It is intended for use with human fecal samples from patients with gastrointestinal symptoms to aid in the diagnosis of disease caused by Shiga toxin producing Escherichia coli (STEC). It may be used with fecal specimens, or broth or plate cultures derived from fecal specimens. The test results should be considered in conjunction with the patient history.
TECHLAB, INC.
T30625
In Commercial Distribution

  • 00857031002196 ()


  • 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)
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)
Hematoxylin, 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8830-M250
In Commercial Distribution

  • 00615233001672 ()
8830-M250

  • Haematoxylin and eosin (H&E) stain control IVD, kit
H&E Stain Kit #1
SAKURA FINETEK U.S.A., INC.
6190
In Commercial Distribution

  • 00615233000040 ()
6190

  • Haematoxylin and eosin (H&E) stain control IVD, kit
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211087 ()


  • Total immunoglobulin E (IgE total) IVD, reagent
No Description
REMEL EUROPE LIMITED
R2474096
In Commercial Distribution

  • 05056080501673 ()


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

  • 00817273020280 ()


  • Anti-E [RH0003] antibody screen IVD, control
No Description
Biomet Orthopedics, LLC
32-423335
In Commercial Distribution

  • 00880304609877 ()

  • SIZE E
32-423335

  • Surgical implant template, reusable
No Description
Biomet Orthopedics, LLC
010002699
In Commercial Distribution

  • 00880304566194 ()

  • 36MM E
010002699

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
010002692
In Commercial Distribution

  • 00880304566149 ()

  • 32MM E
010002692

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
010002665
In Commercial Distribution

  • 00880304565975 ()

  • 36MM E
010002665

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
010002717
In Commercial Distribution

  • 00880304566293 ()

  • SIZE E
010002717

  • Orthopaedic implant impactor, reusable
No Description
Biomet Orthopedics, LLC
010002683
In Commercial Distribution

  • 00880304566064 ()

  • 28MM E
010002683

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
010002658
In Commercial Distribution

  • 00880304565920 ()

  • 32MM E
010002658

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
010002649
In Commercial Distribution

  • 00880304565845 ()

  • 28MM E
010002649

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
010002631
In Commercial Distribution

  • 00880304565746 ()

  • 36MM E
010002631

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
010002624
In Commercial Distribution

  • 00880304565678 ()

  • 32MM E
010002624

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
010002615
In Commercial Distribution

  • 00880304565586 ()

  • 28MM E
010002615

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
010002605
In Commercial Distribution

  • 00880304565487 ()

  • 36MM E
010002605

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
110018392
In Commercial Distribution

  • 00880304675544 ()

  • SIZE E
110018392

  • Bone-resection orthopaedic reamer, reusable
No Description
Biomet Orthopedics, LLC
31-301885
In Commercial Distribution

  • 00880304484375 ()

  • SIZE E
31-301885

  • Fluted surgical drill bit, reusable
No Description
Biomet Orthopedics, LLC
424469
In Commercial Distribution

  • 00880304373747 ()

  • SIZE - E
424469

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
424464
In Commercial Distribution

  • 00880304373716 ()

  • SIZE - E
424464

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
424454
In Commercial Distribution

  • 00880304373655 ()

  • SIZE - E
424454

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
31-149135
In Commercial Distribution

  • 00880304543782 ()

  • SIZE E
31-149135

  • Femoral stem prosthesis trial
No Description
Biomet Orthopedics, LLC
31-149105
In Commercial Distribution

  • 00880304543713 ()

  • SIZE E
31-149105

  • Orthopaedic broach
No Description
Biomet Orthopedics, LLC
31-301365
In Commercial Distribution

  • 00880304490116 ()

  • SIZE E
31-301365

  • Bone-resection orthopaedic reamer, reusable
No Description
Zimmer, Inc.
42-5381-005-01
In Commercial Distribution

  • 00880304809444 ()

  • Size E
42-5381-005-01

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
42-5381-005-02
In Commercial Distribution

  • 00880304809512 ()

  • Size E
42-5381-005-02

  • Knee tibia prosthesis trial, reusable
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