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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: BZD / COC / M-AMP / MTD / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-28
In Commercial Distribution

  • M90107RD7065281 ()
  • M90107RD7065280 ()

  • Length: 75 Millimeter
07RD7065-28

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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: BZD / OPI-2000
LUMIQUICK DIAGNOSTICS, INC.
07RD7061-04A
In Commercial Distribution

  • M90107RD706104A1 ()
  • M90107RD706104A0 ()

  • Length: 75 Millimeter
07RD7061-04A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: MAMP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7061-03
In Commercial Distribution

  • M90107RD7061031 ()
  • M90107RD7061030 ()

  • Length: 75 Millimeter
07RD7061-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7061-01
In Commercial Distribution

  • M90107RD7061011 ()
  • M90107RD7061010 ()

  • Length: 75 Millimeter
07RD7061-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Precise Sapphire - 60 mL LR Kit
ARTERIOCYTE MEDICAL SYSTEMS, INC.
PRC-SAP-060
In Commercial Distribution

  • M896PRCSAP0601 ()
  • M896PRSAP0600 ()


  • Haematological concentrate system preparation kit, platelet concentration
Precise Sapphire - 120 mL LR Kit
ARTERIOCYTE MEDICAL SYSTEMS, INC.
PRC-SAP-120
In Commercial Distribution

  • M896PRCSAP1201 ()
  • M896PRCSAP1200 ()


  • Haematological concentrate system preparation kit, platelet concentration
Precise Diamond - 120 mL LP Kit
ARTERIOCYTE MEDICAL SYSTEMS, INC.
PRC-DIA-120
In Commercial Distribution

  • M896PRCDIA1201 ()
  • M896PRCDIA1200 ()


  • Haematological concentrate system preparation kit, platelet concentration
Precise Diamond - 60 mL LP Kit
ARTERIOCYTE MEDICAL SYSTEMS, INC.
PRC-DIA-060
In Commercial Distribution

  • M896PRCDIA0600 ()
  • M896PRCDIA0601 ()


  • Haematological concentrate system preparation kit, platelet concentration
No Description
ARTERIOCYTE MEDICAL SYSTEMS, INC.
LTN80-O
In Commercial Distribution

  • M896LTN80O1 ()
  • M896LTN80O0 ()


  • Bone marrow biopsy needle, single-use
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