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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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Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7062-02
In Commercial Distribution

  • M90107RD7062021 ()
  • M90107RD7062020 ()

  • Length: 75 Millimeter
07RD7062-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP / OPI-2000
LUMIQUICK DIAGNOSTICS, INC.
07RD7061-02A
In Commercial Distribution

  • M90107RD706102A1 ()
  • M90107RD706102A0 ()

  • Length: 75 Millimeter
07RD7061-02A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of methadone in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7019
In Commercial Distribution

  • M90107RD70191 ()
  • M90107RD70190 ()

  • Length: 75 Millimeter
07RD7019

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of methamphetamine in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7006
In Commercial Distribution

  • M90107RD70060 ()
  • M90107RD70061 ()

  • Length: 75 Millimeter
07RD7006

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of methamphetamine in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7005
In Commercial Distribution

  • M90107RD70051 ()
  • M90107RD70050 ()

  • Length: 75 Millimeter
07RD7005

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
immunochromatographic test (IVD) for Human chorionic gonadotropin beta-subunit (beta-HCG)
LUMIQUICK DIAGNOSTICS, INC.
07RD7001
In Commercial Distribution

  • M90107RD70011 ()
  • M90107RD70010 ()

  • Length: 72 Millimeter
07RD7001

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid
Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
TruMAR0-O-80
In Commercial Distribution

  • M896TRUMAR0O800 ()
  • M896TRUMAR0O801 ()
TruMAR0-O-80

  • Haematological concentrate system preparation kit, platelet concentration
Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
TruMAR0
In Commercial Distribution

  • M896TRUMAR00 ()
  • M896TRUMAR01 ()
TruMAR0

  • Haematological concentrate system preparation kit, platelet concentration
Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
TRU310
Not in Commercial Distribution

  • M896TRU3100 ()
  • M896TRU3101 ()
TRU310

  • Haematological concentrate system preparation kit, platelet concentration
Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
TRU300
In Commercial Distribution

  • M896TRU3000 ()
  • M896TRU3001 ()
TRU300

  • Haematological concentrate system preparation kit, platelet concentration
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