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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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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)

GeneXpert® - 07332940008161

Xpert® Xpress GBS
CEPHEID
XPRSGBS-10
In Commercial Distribution

  • 07332940008161 ()
XPRSGBS-10

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

Xpert® - 07332940007669

GBS LB XC
CEPHEID
GXGBSLBXC
In Commercial Distribution

  • 07332940007669 ()
GXGBSLBXC-120

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

Xpert® - 07332940007652

GBS LB XC
CEPHEID
GXGBSLBXC
In Commercial Distribution

  • 07332940007652 ()
GXGBSLBXC-10

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

Xpert GBS LB - 07332940000882

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

  • 07332940000882 ()
GXGBS-LB-10

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

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)

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)
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