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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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Xpert GBS LB - 07332940000806

Xpert GBS LB kit; 120 test kit
CEPHEID
GXGBS-LB-120
In Commercial Distribution

  • 07332940000806 ()
GXGBS-LB-120

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

Xpert GBS - 07332940000127

Xpert GBS kit; 10 test kit
CEPHEID
GXGBS-100N-10
In Commercial Distribution

  • 07332940000127 ()
GXGBS-100N-10

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

AmpliVue - 30014613312024

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)

Solana - 30014613336440

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)

NovaLisa Influenza Virus B IgG - ENTIINFG03000

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).
Gold Standard Diagnostics Frankfurt GmbH
INFG0300
In Commercial Distribution

  • ENTIINFG03000 ()
INFG0300

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EP - 06974849369281

No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
50 tests/kit
In Commercial Distribution

  • 06974849369281 ()


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

Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR) - 06974849369274

No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
48 tests/kit
In Commercial Distribution

  • 06974849369274 ()


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

Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR) - 06974849369267

No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
50 tests/kit
In Commercial Distribution

  • 06974849369267 ()


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

Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR) - 06974849369250

No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
20 tests/kit
In Commercial Distribution

  • 06974849369250 ()


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

Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR) - 06974849369243

No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
50 tests/kit
In Commercial Distribution

  • 06974849369243 ()


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