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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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Lgc Clinical Diagnostics, Inc.
2000-0071
In Commercial Distribution

  • 00816784021007 ()


  • Hepatitis B virus antigen/antibody marker IVD, control
ACCURUN 125 Anti-HBs 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0077
In Commercial Distribution

  • 00816784020345 ()
2015-0077

  • Hepatitis B virus antigen/antibody marker IVD, control
ACCURUN 120 HAV IgG 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0073
In Commercial Distribution

  • 00816784020314 ()
2015-0073

  • Hepatitis B virus antigen/antibody marker IVD, control
ACCURUN 115 Hepatitis B Core IgG 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0070
In Commercial Distribution

  • 00816784020284 ()
2015-0070

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, control
ACCURUN 113 Hepatitis B Core IgM 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0068
In Commercial Distribution

  • 00816784020277 ()
2015-0068

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
ACCURUN 52 Multi-Marker Hepatitis 2 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0043
In Commercial Distribution

  • 00816784020208 ()
2000-0043

  • Hepatitis B virus antigen/antibody marker IVD, control
ACCURUN 51 Multi-Marker Hepatitis 1 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0041
In Commercial Distribution

  • 00816784020192 ()
2000-0041

  • Hepatitis B virus antigen/antibody marker IVD, control
ACCURUN 51 Multi-Marker Hepatitis 1 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0040
In Commercial Distribution

  • 00816784020185 ()
2000-0040

  • Hepatitis B virus antigen/antibody marker IVD, control
An in vitro diagnostic test for the detection of influenza A and influenza B viral nucleoprotein antigens from nasopharyngeal secretion specimens in symptomatic patients.
NANO-DITECH CORPORATION
TF8147
In Commercial Distribution

  • 00895160002526 ()
  • 10895160002523 ()
TF8147

  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay
The NATtrol™ Influenza A/B 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 these organisms. 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™ Influenza A/B 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™ Influenza A/B Positive Control
In Commercial Distribution

  • 01220000260085 ()
NATFLUAB-6C-IVD

  • Influenza A/B virus nucleic acid IVD, control
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