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 / OPI
RAPID DIAGNOSTICS INC
07RD7062-05
In Commercial Distribution

  • 00817830020838 ()

  • Length: 75 Millimeter
07RD7062-05

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / OPI-II / THC
RAPID DIAGNOSTICS INC
07RD7062-04A
In Commercial Distribution

  • 00817830020821 ()

  • Length: 75 Millimeter
07RD7062-04A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / OPI / THC
RAPID DIAGNOSTICS INC
07RD7062-04
In Commercial Distribution

  • 00817830020814 ()

  • Length: 75 Millimeter
07RD7062-04

  • 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-II / THC
RAPID DIAGNOSTICS INC
07RD7062-03A
In Commercial Distribution

  • 00817830020807 ()

  • Length: 75 Millimeter
07RD7062-03A

  • 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 / THC
RAPID DIAGNOSTICS INC
07RD7062-03
In Commercial Distribution

  • 00817830020791 ()

  • Length: 75 Millimeter
07RD7062-03

  • 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
RAPID DIAGNOSTICS INC
07RD7062-02
In Commercial Distribution

  • 00817830020784 ()

  • 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: AMP / COC / THC
RAPID DIAGNOSTICS INC
07RD7062-01
In Commercial Distribution

  • 00817830020777 ()

  • Length: 75 Millimeter
07RD7062-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP
RAPID DIAGNOSTICS INC
07RD7060-11
In Commercial Distribution

  • 00817830020760 ()

  • Length: 75 Millimeter
07RD7060-11

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: THC
RAPID DIAGNOSTICS INC
07RD7060-10
In Commercial Distribution

  • 00817830020753 ()

  • Length: 75 Millimeter
07RD7060-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: PCP
RAPID DIAGNOSTICS INC
07RD7060-09
In Commercial Distribution

  • 00817830020746 ()

  • Length: 75 Millimeter
07RD7060-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: OXY
RAPID DIAGNOSTICS INC
07RD7060-08
In Commercial Distribution

  • 00817830020739 ()

  • Length: 75 Millimeter
07RD7060-08

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: OPI-II
RAPID DIAGNOSTICS INC
07RD7060-07A
In Commercial Distribution

  • 00817830020722 ()

  • Length: 75 Millimeter
07RD7060-07A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: OPI
RAPID DIAGNOSTICS INC
07RD7060-07
In Commercial Distribution

  • 00817830020715 ()

  • Length: 75 Millimeter
07RD7060-07

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: MTD
RAPID DIAGNOSTICS INC
07RD7060-06
In Commercial Distribution

  • 00817830020708 ()

  • Length: 75 Millimeter
07RD7060-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP
RAPID DIAGNOSTICS INC
07RD7060-05
In Commercial Distribution

  • 00817830020692 ()

  • Length: 75 Millimeter
07RD7060-05

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC
RAPID DIAGNOSTICS INC
07RD7060-04
In Commercial Distribution

  • 00817830020685 ()

  • Length: 75 Millimeter
07RD7060-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD
RAPID DIAGNOSTICS INC
07RD7060-03
In Commercial Distribution

  • 00817830020678 ()

  • Length: 75 Millimeter
07RD7060-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BAR
RAPID DIAGNOSTICS INC
07RD7060-02
In Commercial Distribution

  • 00817830020661 ()

  • Length: 75 Millimeter
07RD7060-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP
RAPID DIAGNOSTICS INC
07RD7060-01
In Commercial Distribution

  • 00817830020654 ()

  • Length: 75 Millimeter
07RD7060-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
UTAK LABORATORIES, INC.
UBP H F V DU
In Commercial Distribution

  • B30001346000010 ()
  • B30001346000011 ()
  • B30001346000012 ()
  • B30001346000013 ()
  • B30001346000016 ()
  • B30001346000017 ()
  • B30001346000018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0127
Not in Commercial Distribution

  • 00815381020093 ()
RFIT-ASY-0127

  • Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0126
Not in Commercial Distribution

  • 00815381020086 ()
RFIT-ASY-0126

  • Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
No Description
Aktina Corp.
51-250
In Commercial Distribution

  • B365512500 ()


  • Indexed-immobilization patient positioning system
No Description
Aktina Corp.
11-217
In Commercial Distribution

  • B365112170 ()


  • Radiological whole-body positioner
No Description
Aktina Corp.
11-211
In Commercial Distribution

  • B365112110 ()


  • Radiological whole-body positioner
Detection of Syphilis, 10 samples
ARLINGTON SCIENTIFIC, INC.
NC-907000
In Commercial Distribution

  • 00816057020980 ()

  • Total Volume: 0.5 Milliliter
NC-907000

  • Treponema pallidum reagin antibody IVD, kit, agglutination
The Praxis™ Extended RAS Panel assay is designed specifically for the detection of 56 mutations from exons 2, 3, and 4 of the KRAS and NRAS genes using the Illumina MiSeqDx Instrument. The assay has been configured for 2 runs with a maximum of 10 samples plus 2 controls per run. Illumina provides the following reagents for the Illumina Praxis Extended RAS Panel: 20012195, Praxis Extended RAS Panel – 1/6; 20012196, Praxis Extended RAS Panel – 1A; 20012197, Praxis Extended RAS Panel – 1B; 20012198, Praxis Extended RAS Panel – 2/6; 20012199, Praxis Extended RAS Panel – 3/6; 20012200, Praxis Extended RAS Panel – 3A; 20012201, Praxis Extended RAS Panel – 3B; 20012202, Praxis Extended RAS Panel – 4/6; 20012203, Praxis Extended RAS Panel – 5/6; and 20012204, Praxis Extended RAS Panel – 6/6.
ILLUMINA, INC.
20012431
Not in Commercial Distribution

  • 00816270020088 ()
20012431

  • Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
Stool Bacterial Pathogens Panel Cartridge with sample prep device.
GREAT BASIN SCIENTIFIC, INC.
GBSBPP-10
In Commercial Distribution

  • B178SBPP102 ()
  • B178GBSBPP100 ()
GBSBPP-10

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
Pocguide Multi-Drug Test Panel (CLIA Waived), 14-Panel, 25T/Box; AMP1000/BAR300/BUP10/BZO300/COC300/EDDP300/MET1000/MDMA500/OPI2000/MTD300/OXY100/PCP25/TCA1000/THC50THC50
Hangzhou Aichek Medical Technology Co., Ltd.
1
In Commercial Distribution

  • 06978151200058 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Pocguide Multi-Drug Test Panel (CLIA Waived), 14-Panel, 25T/Box; AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/MET500/MDMA500/MOP300/MTD300/OXY100/PCP25/TCA1000/THC50
Hangzhou Aichek Medical Technology Co., Ltd.
1
In Commercial Distribution

  • 06978151200034 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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