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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® - 00816784020192

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® - 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

CHANG Medium D - 00810195240637

CHANG Medium D with L-Glutamine. 500mL bottle.
IRVINE SCIENTIFIC, LLC
T105-500ML
In Commercial Distribution

  • 00810195240637 ()
T105

  • Cell culture medium IVD

CHANG Medium D - 00810195240620

CHANG Medium D with L-Glutamine. 100mL bottle.
IRVINE SCIENTIFIC, LLC
T105-100ML
In Commercial Distribution

  • 00810195240620 ()
T105

  • Cell culture medium IVD
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