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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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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)

Panther Fusion® - 15420045510890

The Panther Fusion® GBS assay is an automated qualitative in vitro diagnostic test utilizing realtime PCR for detection of Group B Streptococcus DNA.
Hologic, Inc.
KIT, GBS ASSAY CARTRIDGES, 96-TEST, FUSION, IVD
In Commercial Distribution

  • 15420045510890 ()
PRD-04484

  • 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)

B&B Bubbler - 00850008733055

Water Seal CPAP Valve, 24 units
B&B Medical Technologies
25324
In Commercial Distribution

  • 00850008733055 ()
25324

  • PEEP valve, single-use

B&B Bubbler - 00850008733031

Water Seal CPAP Valve, 12 units
B&B Medical Technologies
25312
In Commercial Distribution

  • 00850008733031 ()
25312

  • PEEP valve, single-use
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