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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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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

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)

Portrait Toxigenic C. difficile Assay - B178GBCDIFF100

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)

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

cobas® Influenza A/B Quality Control Kit for use on the cobas® Liat® System - 00875197005639

No Description
Roche Molecular Systems, Inc.
07402660190
In Commercial Distribution

  • 00875197005639 ()
07402660190

  • Influenza A/B virus nucleic acid IVD, control

Alere™ i Influenza A & B Control Swab Kit - 10811877010811

Control Swabs intended for use only with the Alere i Inuenza A & B product.
Alere Scarborough, Inc.
425-080
Not in Commercial Distribution

  • 10811877010811 ()


  • Influenza A/B virus nucleic acid IVD, control

ID NOW Influenza A & B Control Swab Kit - 10811877010439

Control Swabs intended for use only with the ID NOW Influenza A & B product.
Alere Scarborough, Inc.
425-080
Not in Commercial Distribution

  • 10811877010439 ()


  • Influenza A/B virus nucleic acid IVD, control

ID NOW Influenza A & B 2 Control Swab Kit - 10811877011221

Control Swabs intended for use only with the ID NOW Influenza A & B 2 product.
Alere Scarborough, Inc.
425-080
In Commercial Distribution

  • 10811877011221 ()


  • Influenza A/B virus nucleic acid IVD, control
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