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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 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
Ceramic Liner - Size 28
Encore Medical, L.P.
498-28-048
In Commercial Distribution

  • 00888912087537 ()


  • Ceramic acetabular liner
Ceramic Liner - Size 32
Encore Medical, L.P.
498-32-064
In Commercial Distribution

  • 00888912087636 ()


  • Ceramic acetabular liner
Ceramic Liner - Size 32
Encore Medical, L.P.
498-32-060
In Commercial Distribution

  • 00888912087629 ()


  • Ceramic acetabular liner
Ceramic Liner - Size 32
Encore Medical, L.P.
498-32-056
In Commercial Distribution

  • 00888912087612 ()


  • Ceramic acetabular liner
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.
HYCOR BIOMEDICAL LLC
W007
Not in Commercial Distribution

  • 00816879022032 ()
744470

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.
HYCOR BIOMEDICAL LLC
G016
Not in Commercial Distribution

  • 00816879022025 ()
743420

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