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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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No Description
DIESSE DIAGNOSTICA SENESE SPA
81193
In Commercial Distribution

  • 08033891327538 ()
81193

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
VITROS Immunodiagnostic Products Anti-HBc IgM Controls
ORTHO CLINICAL DIAGNOSTICS
6801427
In Commercial Distribution

  • 10758750001200 ()
  • 20758750001207 ()
6801427

  • Hepatitis B virus surface immunoglobulin M (IgM) antibody IVD, control
Gold Standard Diagnostics Influenza B IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3010
In Commercial Distribution

  • B350GSD0130100 ()
GSD01-3010

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Response Biomedical Corp
C1135
Not in Commercial Distribution

  • 10627966005190 ()


  • Influenza A/B virus antigen IVD, control
DS5 HbA1c Calibrator (1 and 2) (2 x 4 x 0.5mL)
DREW SCIENTIFIC, INC.
014-380SA
In Commercial Distribution

  • 00817274020210 ()


  • Hepatitis B virus e-antigen total antibody IVD, calibrator
DS5 HbA1c Calibrator (4x 0.5mL L1, 4x 0.5mL L2, 1x 6mL Diluent)
DREW SCIENTIFIC, INC.
014-380
In Commercial Distribution

  • 00817274020203 ()


  • Hepatitis B virus e-antigen total antibody IVD, calibrator
No Description
GREAT BASIN SCIENTIFIC, INC.
GBGBS-10
In Commercial Distribution

  • B178GBGBS100 ()
  • B178GBGBS102 ()
GBGBS-10

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Bion Enterprises, Ltd.
QAB-1504
In Commercial Distribution

  • B110QAB15040 ()
QAB-1504

  • Influenza A/B virus antigen IVD, control
Solana GBS Assay
DIAGNOSTIC HYBRIDS, INC.
M311
In Commercial Distribution

  • 30014613336440 ()
M311

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
AmpliVue GBS Assay
QUIDEL CORPORATION
GBS Assay
Not in Commercial Distribution

  • 30014613312024 ()
M202

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
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