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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
CRYOcheck Chromogenic Factor IX is for clinical laboratory use in the quantitative determination of factor IX activity in 3.2% citrated human plasma. It is intended to be used in identifying factor IX deficiency and as an aid in the management of hemophilia B in individuals aged 2 years and older. For in vitro diagnostic use
Precision Biologic Inc
CCCF09
In Commercial Distribution

  • 00843876000565 ()
CCCF09

  • Coagulation factor IX IVD, kit, chromogenic
Coxsackievirus B5 Monoclonal Antibody
EMD Millipore Corporation
3308
Not in Commercial Distribution

  • 04053252332371 ()
3308

  • Coxsackie A/B virus antigen IVD, reagent
Coxsackievirus B1 Monoclonal Antibody
EMD Millipore Corporation
3304
Not in Commercial Distribution

  • 04053252326264 ()
3304

  • 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
Coxsackievirus B Control Slides
EMD Millipore Corporation
5075
Not in Commercial Distribution

  • 04053252729225 ()
5075

  • Coxsackie A/B virus antigen IVD, reagent
Coxsackievirus A9 Monoclonal Antibody
EMD Millipore Corporation
3301
Not in Commercial Distribution

  • 04053252672989 ()
3301

  • Coxsackie A/B virus antigen IVD, reagent
Coxsackie Antibody Set
EMD Millipore Corporation
3350
Not in Commercial Distribution

  • 04053252585258 ()
3350

  • Coxsackie A/B virus antigen IVD, reagent
Coxsackievirus B2 Monoclonal Antibody
EMD Millipore Corporation
3305
Not in Commercial Distribution

  • 04053252516092 ()
3305

  • Coxsackie A/B virus antigen IVD, reagent
Coxsackievirus B6 Monoclonal Antibody
EMD Millipore Corporation
3309
Not in Commercial Distribution

  • 04053252472985 ()
3309

  • Coxsackie A/B virus antigen IVD, reagent
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