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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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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
Coxsackievirus B4 Monoclonal Antibody
EMD Millipore Corporation
3307
Not in Commercial Distribution

  • 04053252408489 ()
3307

  • Coxsackie A/B virus antigen 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
NeuMoDx GBS Test Strip
Neumodx Molecular, Inc.
200400
Not in Commercial Distribution

  • 10814278020045 ()
  • 00814278020048 ()
200400

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, reagent
Toxi-Titer Plate, 48 Wells
MARDX DIAGNOSTICS, INC.
B1029-70D
In Commercial Distribution

  • 05391516747998 ()
B1029-70D

  • Clostridium difficile toxin A/B antigen IVD, reagent
Bartels® Cytotoxicity Assay for Clostridium difficile Toxin Product B1029-70, Store Toxi-Titer Plate @ 35-37 °C, Store Reagents @ 2-8 °C, 48 Tests
MARDX DIAGNOSTICS, INC.
B1029-70
In Commercial Distribution

  • 05391516747950 ()
B1029-70

  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
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