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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 Clostridium difficile Toxin/Antitoxin Kit is intended for use in conjunction with the tissue culture cytotoxicity assay for the confirmation of Clostridium difficile toxin in patient specimens. The kit includes a toxin control reagent and a specific C. difficile antitoxin for use in a tissue culture assay. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history.
TECHLAB, INC.
T5000
In Commercial Distribution

  • 00857031002066 ()


  • Clostridium difficile antigen IVD, kit, cell culture assay
Uni-Gold™ C. difficile GDH Controls, 1 Positive and 1 Negative
MARDX DIAGNOSTICS, INC.
1206641
In Commercial Distribution

  • 05391516748803 ()
1206641

  • Clostridium difficile antigen IVD, control
Uni-Gold™ C. difficile GDH, 20 Tests
MARDX DIAGNOSTICS, INC.
1206640
In Commercial Distribution

  • 05391516748797 ()
1206640

  • Clostridium difficile antigen IVD, kit, agglutination
No Description
DIAGNOSTICA STAGO
00724
In Commercial Distribution

  • 13607450007241 ()
  • 03607450007244 ()


  • Coagulation factor IX IVD, kit, clotting
HemosIL Factor IX Deficient Plasma (10 X 1 mL)
INSTRUMENTATION LABORATORY COMPANY
00020011900
In Commercial Distribution

  • 08426950478553 ()
  • 18426950478550 ()
00020011900

  • Coagulation factor IX IVD, kit, clotting
No Description
Bion Enterprises, Ltd.
IB-2112
In Commercial Distribution

  • B110IB21120 ()
IB-2112

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, reagent
Group B Latex Reagent
PRO-LAB, INCORPORATED
PL.1032
In Commercial Distribution

  • 10628429001339 ()
PL.1032

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, reagent
Coxsackie A9/A24 Control Slide
EMD Millipore Corporation
50209
Not in Commercial Distribution

  • 04061841171737 ()
50209

  • Coxsackie A/B virus antigen IVD, reagent
Coxsackie B Control Slide
EMD Millipore Corporation
50208
Not in Commercial Distribution

  • 04061841171218 ()
50208

  • Coxsackie A/B virus antigen IVD, reagent
Coxsackievirus B Blend Monoclonal Antibodies
EMD Millipore Corporation
3303
Not in Commercial Distribution

  • 04053252734557 ()
3303

  • Coxsackie A/B virus antigen IVD, reagent
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