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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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illumigene C. difficile External Control Kit - 00840733101120

The illumigene C. difficile External Control Kit contains Positive and Negative Control Reagents for use with the illumigene C. difficile test kit. External controls are used as part of a routine quality control program.
MERIDIAN BIOSCIENCE, INC.
279920
Not in Commercial Distribution

  • 00840733101120 ()
279920

  • Clostridium difficile nucleic acid IVD, control

QC Sets and Panels: Helix Elite™ - 70845357042711

QC Sets and Panels: Helix Elite™ C. difficile Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8227
In Commercial Distribution

  • 70845357042711 ()
8227

  • Clostridium difficile nucleic acid IVD, control

QC Sets and Panels: Helix Elite™ - 70845357041370

Cepheid Xpert® C. difficile/Epi Control Panel
MICROBIOLOGICS INC.
8200 Cepheid Xpert® C. difficile/Epi Control Panel
In Commercial Distribution

  • 70845357041370 ()
8200

  • Clostridium difficile nucleic acid IVD, control

Echovirus Negative Control - B110ECN44100

No Description
Bion Enterprises, Ltd.
ECN-4410
Not in Commercial Distribution

  • B110ECN44100 ()
ECN-4410

  • Multiple enterovirus immunoglobulin G (IgG) antibody IVD, control

Echovirus IgG Control - B110ECG44200

No Description
Bion Enterprises, Ltd.
ECG-4420
Not in Commercial Distribution

  • B110ECG44200 ()
ECG-4420

  • Multiple enterovirus immunoglobulin G (IgG) antibody IVD, control

Exact Diagnostics - 00812242030734

C. difficile Verification Panel
EXACT DIAGNOSTICS, LLC
CDFP200
In Commercial Distribution

  • 00812242030734 ()
CDFP200

  • Clostridium difficile nucleic acid IVD, control

Quidel Molecular - 30014613311089

QMol CDIFF Control Set
DIAGNOSTIC HYBRIDS, INC.
M108
In Commercial Distribution

  • 30014613311089 ()
M108

  • Clostridium difficile nucleic acid IVD, control

OrthoFlex - 00190730002341

OrtFlx Com McLaughlin 022 L1/2 Rx -6º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-841
In Commercial Distribution

  • 00190730002341 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730001962

OrtFlx Com McLaughlin 018 L1/2 Rx -6º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-741
In Commercial Distribution

  • 00190730001962 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730001924

OrtFlx Com McLaughlin 018 U4/5 Rx -7º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-730
In Commercial Distribution

  • 00190730001924 ()


  • Orthodontic bracket, plastic, single-use
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