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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
SEKISUI DIAGNOSTICS, LLC
1034
In Commercial Distribution

  • 10742860100403 ()
  • 00742860100406 ()


  • Influenza A/B virus antigen IVD, control
No Description
SEKISUI DIAGNOSTICS, LLC
1011
In Commercial Distribution

  • 00742860100383 ()
  • 10742860100380 ()


  • Influenza A/B virus antigen IVD, control
No Description
Bion Enterprises, Ltd.
QAB-1504
In Commercial Distribution

  • B110QAB15040 ()
QAB-1504

  • Influenza A/B virus antigen IVD, control
No Description
DIESSE DIAGNOSTICA SENESE SPA
81193
In Commercial Distribution

  • 08033891327538 ()
81193

  • 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
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
No Description
DIASORIN SPA
318130
In Commercial Distribution

  • 08056771103367 ()
  • 18056771103364 ()


  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
No Description
DIASORIN SPA
P001931
In Commercial Distribution

  • 08056771102360 ()


  • Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN SPA
P001929
In Commercial Distribution

  • 08056771102346 ()


  • Hepatitis B virus e-antigen total antibody IVD, kit, enzyme immunoassay (EIA)
Alinity s Anti-HBc Reagent Kit
Abbott GmbH
06P0660
In Commercial Distribution

  • 00380740117207 ()
06P0660

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
ABBOTT PRISM HBcore Assay Kit
ABBOTT LABORATORIES
6E66-68
Not in Commercial Distribution

  • 00380740062965 ()
06E6668

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2692-9601 M
Not in Commercial Distribution

  • 04049016028352 ()


  • Influenza B virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2692-9601 G
In Commercial Distribution

  • 04049016028345 ()


  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2692-9601 A
Not in Commercial Distribution

  • 04049016028338 ()


  • Influenza B virus immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus B in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3796
Not in Commercial Distribution

  • 00404847437966 ()
EIA-3796

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus B in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3796
In Commercial Distribution

  • 04048474037968 ()
EIA-3796

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
BD MAX™ GBS
BECTON, DICKINSON AND COMPANY
441772
In Commercial Distribution

  • 00382904417727 ()
441772

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Control Swabs ntended for use only with BinaxNOW™ Influenza A & B 2 Card product.
Alere Scarborough, Inc.
575-080
In Commercial Distribution

  • 10811877010989 ()


  • Influenza A/B virus antigen IVD, control
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