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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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ACCURUN 31 EBV IgM 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0038
In Commercial Distribution

  • 00816784020161 ()
2000-0038

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, control
ACCURUN 30 EBV IgG 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0037
In Commercial Distribution

  • 00816784020154 ()
2000-0037

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, control
ACCURUN 26 ToRC IgM Series 5000 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0035
In Commercial Distribution

  • 00816784020147 ()
2000-0035

  • Multiple infectious organism/newborn TORCH screen IVD, control
ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0063
In Commercial Distribution

  • 00816784020932 ()


  • Hepatitis B virus antigen/antibody marker IVD, control
  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0065
In Commercial Distribution

  • 00816784020925 ()


  • Hepatitis B virus antigen/antibody marker IVD, control
  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 803 NUCLEIC ACID HIV, HCV, HBV 10 x 1.2 mL
Lgc Clinical Diagnostics, Inc.
2035-0007
In Commercial Distribution

  • 00816784020710 ()
2035-0007

  • PCR/NAT negative control IVD
ACCURUN 325 Series 700 HBV DNA 5 x 4.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0098
In Commercial Distribution

  • 00816784020604 ()
2020-0098

  • Hepatitis B virus nucleic acid IVD, control
ACCURUN 325 Series 200 HBV DNA 5 x 4.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0096
In Commercial Distribution

  • 00816784020598 ()
2020-0096

  • Hepatitis B virus nucleic acid IVD, control
ACCURUN 325 Series 370 HBV DNA Positive Control 5 x 0.6 mL
Lgc Clinical Diagnostics, Inc.
2020-0095
In Commercial Distribution

  • 00816784020581 ()
2020-0095

  • Hepatitis B virus nucleic acid IVD, control
ACCURUN 156 Reagin (Syphilis) 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0094
In Commercial Distribution

  • 00816784020482 ()
2015-0094

  • Treponema pallidum reagin antibody IVD, control
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