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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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No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
6800-30-50844
In Commercial Distribution

  • 06944904006550 ()


  • Patient monitoring system module, multiple-gas
A rapid, automated, molecular test for the qualitative detection of COVID-19 viral nucleic acid in respiratory specimens.
Alere Scarborough, Inc.
190-000
Not in Commercial Distribution

  • 10811877011269 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Intersurgical Incorporated
STR/019
In Commercial Distribution

  • 08058323030831 ()
  • 08058323016606 ()


  • Straight/elbow breathing circuit connector, single-use
rapid ID 32 E is a standardized system for the identification of Enterobacteriaceae in 4 hours
BIOMERIEUX SA
RAPID ID 32 E
In Commercial Distribution

  • 03573026066574 ()
  • 03573026588649 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
rapid ID 32 STREP is a standardized system for the identification of streptococci and enterococci, and those most common related organisms, in 4 hours
BIOMERIEUX SA
RAPID ID 32 STREP
In Commercial Distribution

  • 03573026066536 ()
  • 03573026588625 ()


  • Multiple Streptococcus bacterial species culture isolate identification IVD, kit
rapid ID 32 A is a standardized system for the identification of anaerobes in 4 hours
BIOMERIEUX SA
RAPID ID 32 A
In Commercial Distribution

  • 03573026066420 ()
  • 03573026588564 ()


  • Multiple anaerobic bacteria species culture isolate identification IVD, kit
A rapid, automated, molecular test for the qualitative detection of COVID-19 viral nucleic acid in anterior nasal swab and nasopharyngeal swab specimens.
Alere Scarborough, Inc.
192-000
In Commercial Distribution

  • 00811877011354 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
The ID NOW™ Instrument is a portable, fluorescence based instrument intended to be used for the processing and analysis of Abbott molecular diagnostic assays.
Alere Scarborough, Inc.
EQ00200XS
In Commercial Distribution

  • 00811877010616 ()


  • Isothermal nucleic acid amplification analyser IVD, laboratory
The ID NOW™ Instrument is a portable, fluorescence based instrument intended to be used for the processing and analysis of Abbott molecular diagnostic assays.
Alere Scarborough, Inc.
EQ00200X
In Commercial Distribution

  • 00811877010593 ()


  • Isothermal nucleic acid amplification analyser IVD, laboratory
No Description
ACCUTRON, INC.
23126
Not in Commercial Distribution

  • 00813830020106 ()
23126

  • Medical gas pipeline system
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