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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 NATtrol™ Clostridium difficile Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Clostridium difficile Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
ZEPTOMETRIX CORPORATION
NATtrol™ Clostridium difficile Positive Control
In Commercial Distribution

  • 01220000260054 ()
NATCDI-6MC-IVD

  • Clostridium difficile nucleic acid IVD, control
QMol CDIFF Control Set
DIAGNOSTIC HYBRIDS, INC.
M108
In Commercial Distribution

  • 30014613311089 ()
M108

  • Clostridium difficile nucleic acid IVD, control
C. difficile Verification Panel
EXACT DIAGNOSTICS, LLC
CDFP200
In Commercial Distribution

  • 00812242030734 ()
CDFP200

  • Clostridium difficile nucleic acid IVD, control
No Description
Bion Enterprises, Ltd.
ECN-4410
Not in Commercial Distribution

  • B110ECN44100 ()
ECN-4410

  • Multiple enterovirus immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
ECG-4420
Not in Commercial Distribution

  • B110ECG44200 ()
ECG-4420

  • Multiple enterovirus immunoglobulin G (IgG) antibody IVD, control
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
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
MALLEABLE B/B FINGER P LG
TETRA MEDICAL SUPPLY CORP.
4015P3
In Commercial Distribution

  • 00614138115026 ()
4015P3

  • Hand/finger splint, reusable
MALLEABLE B/B FINGER P MD
TETRA MEDICAL SUPPLY CORP.
4015P2
In Commercial Distribution

  • 00614138115019 ()
4015P2

  • Hand/finger splint, reusable
MALLEABLE B/B FINGER P SM
TETRA MEDICAL SUPPLY CORP.
4015P1
In Commercial Distribution

  • 00614138115002 ()
4015P1

  • Hand/finger splint, reusable
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