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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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QMol GBS Control Set
DIAGNOSTIC HYBRIDS, INC.
M116
In Commercial Distribution

  • 30014613311164 ()
M116

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
Bordetella Pertussis IgG kit is an Enzyme Linked Immunosorbent assay (ELISA) for the qualitative detection of specific IgG antibodies to Bordetella pertussis.
SAVYON DIAGNOSTICS LTD
A2231-01M
In Commercial Distribution

  • 07290016332636 ()
A2231-01M

  • Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
VITROS Immunodiagnostic Products Anti-HBc Controls
ORTHO CLINICAL DIAGNOSTICS
6801430
In Commercial Distribution

  • 10758750001231 ()
  • 20758750001238 ()
6801430

  • Hepatitis B virus core total antibody IVD, control
OSOM Ultra Flu A&B Controls 5 Test
SEKISUI DIAGNOSTICS, LLC
1005
In Commercial Distribution

  • 00742860100215 ()
  • 10742860100212 ()
1005

  • Influenza A/B virus antigen IVD, control
No Description
SEKISUI DIAGNOSTICS, LLC
191
Not in Commercial Distribution

  • 00742860100147 ()
  • 10742860100144 ()
191

  • Influenza A/B virus antigen IVD, control
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 International Inc
EIA-3796
In Commercial Distribution

  • 00840239037961 ()
EIA-3796

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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 ARIES® GBS Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) nucleic acid from Lim Broth enriched vaginal-rectal specimen swabs obtained from pregnant women.
LUMINEX CORPORATION
50-10021
Not in Commercial Distribution

  • 00840487100165 ()


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