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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® - 00816784020185

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

ACCURUN® - 00816784020161

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® - 00816784020154

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® - 00816784020147

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

MassTrak - 00816776020575

MassTrak™ Steroid Serum QC Set 3
WATERS TECHNOLOGIES CORPORATION
186010566IVD
In Commercial Distribution

  • 00816776020575 ()
186010566IVD

  • Multiple steroid hormone IVD, control

MassTrak - 00816776020551

MassTrak™ Steroid Serum QC Set 2
WATERS TECHNOLOGIES CORPORATION
186010565IVD
In Commercial Distribution

  • 00816776020551 ()
186010565IVD

  • Multiple steroid hormone IVD, control

MassTrak - 00816776020438

MassTrak™ Endocrine Steroid Quality Control Set
WATERS TECHNOLOGIES CORPORATION
186009312IVD
In Commercial Distribution

  • 00816776020438 ()
186009312IVD

  • Multiple steroid hormone IVD, control

ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 6 x 3.5 mL - 00816784020932

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 - 00816784020925

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® - 00816784020710

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
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