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

  • 15060392376284 ()
M12018

  • Escherichia coli antigen IVD, kit, agglutination
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211087 ()


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

  • 05056080501673 ()


  • Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA)
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)
"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
Ceramic Liner - Size 32
Encore Medical, L.P.
498-32-052
In Commercial Distribution

  • 00888912087599 ()


  • Ceramic acetabular liner
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