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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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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)
No Description
GREAT BASIN SCIENTIFIC, INC.
GBGBS-10
In Commercial Distribution

  • B178GBGBS100 ()
  • B178GBGBS102 ()
GBGBS-10

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Bion Enterprises, Ltd.
QAB-1504
In Commercial Distribution

  • B110QAB15040 ()
QAB-1504

  • 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
Gold Standard Diagnostics Influenza B IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3010
In Commercial Distribution

  • B350GSD0130100 ()
GSD01-3010

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Control Swabs are intended for use only with the Alere Influenza A & B Test.
Alere Scarborough, Inc.
412-080
Not in Commercial Distribution

  • 10811877010880 ()


  • Influenza A/B virus antigen IVD, control
Control Swabs intended for use only with Alere BinaxNOW® Influenza A & B Card 2 product.
Alere Scarborough, Inc.
575-080
Not in Commercial Distribution

  • 10811877010194 ()


  • Influenza A/B virus antigen IVD, control
No Description
Response Biomedical Corp
C1135
Not in Commercial Distribution

  • 10627966005190 ()


  • Influenza A/B virus antigen IVD, control
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 GBS Assay
DIAGNOSTIC HYBRIDS, INC.
M311
In Commercial Distribution

  • 30014613336440 ()
M311

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
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)
GBS LB XC
CEPHEID
GXGBSLBXC
In Commercial Distribution

  • 07332940007669 ()
GXGBSLBXC-120

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
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 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 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 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)
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)
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)
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)
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)
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)
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)
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)
C. diff Assay Cartridge and Sample Prep Device.
GREAT BASIN SCIENTIFIC, INC.
GBCDIFF-10
In Commercial Distribution

  • B178GBCDIFF100 ()
  • B178GBCDIFF102 ()
GBCDIFF-10

  • Clostridium difficile toxin B nucleic acid IVD, kit, nucleic acid technique (NAT)
  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Water Seal CPAP Valve, 24 units
B&B Medical Technologies
25324
In Commercial Distribution

  • 00850008733055 ()
25324

  • PEEP valve, single-use
Water Seal CPAP Valve, 12 units
B&B Medical Technologies
25312
In Commercial Distribution

  • 00850008733031 ()
25312

  • PEEP valve, single-use
No Description
Lgc Clinical Diagnostics, Inc.
2000-0107
In Commercial Distribution

  • 00850041090108 ()


  • Hepatitis B virus antigen/antibody marker IVD, control
No Description
Lgc Clinical Diagnostics, Inc.
2000-0106
In Commercial Distribution

  • 00850041090092 ()


  • Hepatitis B virus antigen/antibody marker IVD, control
No Description
Lgc Clinical Diagnostics, Inc.
2000-0105
In Commercial Distribution

  • 00850041090061 ()


  • Hepatitis B virus antigen/antibody marker IVD, control
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