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: 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: 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 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
No Description
Bion Enterprises, Ltd.
QRP-6314
Not in Commercial Distribution

  • B110QRP63140 ()
QRP-6314

  • Multiple-genus respiratory virus antigen IVD, control
No Description
AALTO SCIENTIFIC
K898M-5
In Commercial Distribution

  • B085K898M50 ()


  • Multiple urine analyte IVD, control
No Description
AALTO SCIENTIFIC
K897M-5
In Commercial Distribution

  • B085K897M50 ()


  • Multiple urine analyte IVD, control
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-22
In Commercial Distribution

  • M09107RD7065221 ()
  • M09107RD7065220 ()

  • Length: 75 Millimeter
07RD7065-22

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Shiga Toxin Direct Test Cartridge with sample prep device.
GREAT BASIN SCIENTIFIC, INC.
GBSTEC-10
In Commercial Distribution

  • B178GBSTEC102 ()
  • B178GBSTEC100 ()
GBSTEC-10

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE17 model is a panel PC with a 17" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE17
In Commercial Distribution

  • B201CGCORE170 ()
  • B201CGCORE171 ()
CG-CORE17

  • Ultrasound imaging system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
X-MIND trium PAN CBCT version including one removable pan sensor and a CBCT sensor, with control panel on the left
DE GÖTZEN SRL
XMT PAN 3D L
Not in Commercial Distribution

  • D804W09000100 ()
W0900010

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital
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