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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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RAMP® Flu A + B Control Swabs - 10627966005190

No Description
Response Biomedical Corp
C1135
Not in Commercial Distribution

  • 10627966005190 ()


  • Influenza A/B virus antigen IVD, control

Drew Scientific - 00817274020210

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

Drew Scientific - 00817274020203

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

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)

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)
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