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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Strip description for the invitro quantitative determination of HDL-cholesterol, total cholesterol, and triglyceride in human plasma from whole blood samples
ARKRAY USA, INC.
77123
Not in Commercial Distribution

  • 00015482771232 ()
  • 50015482771237 ()


  • Magnesium (Mg2+) IVD, kit, spectrophotometry
The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
LUMINEX CORPORATION
30-001-001
Not in Commercial Distribution

30-001-001

  • Multiple coagulation factor IVD, kit, clotting
The NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection.
Luminex Molecular Diagnostics, Inc
I051C0447
In Commercial Distribution

  • 00840487100417 ()
I051C0447

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
QIAGEN GmbH
1
In Commercial Distribution

  • 04053228048862 ()
691218

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
QIAGEN GmbH
V1
In Commercial Distribution

  • 04053228047438 ()
691224

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood from the fingertip, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek Plus Home Self-Test analyzer.
POLYMER TECHNOLOGY SYSTEMS, INC.
REF 4753
In Commercial Distribution

  • 10381934753017 ()
  • 00381934753010 ()
REF 4753

  • Multiple lipid analyte IVD, kit, spectrophotometry
No Description
THE BINDING SITE GROUP LIMITED
BP228
In Commercial Distribution

  • 05051700002059 ()


  • Kappa/lambda light chain immunoglobulin IVD, control
No Description
Aktina Corp.
11-202
In Commercial Distribution

  • B365112020 ()


  • Radiological whole-body positioner
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
423742
In Commercial Distribution

  • 00815381020529 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0125
Not in Commercial Distribution

  • 00815381020079 ()
RFIT-ASY-0125

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0124
Not in Commercial Distribution

  • 00815381020062 ()
RFIT-ASY-0124

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
ACCUTRON, INC.
49054
In Commercial Distribution

  • 00813830024845 ()
49054

  • Medical gas pipeline system
Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / OPI / THC
RAPID DIAGNOSTICS INC
07RD-7110-22
In Commercial Distribution

  • 00817830022818 ()

  • Length: 75 Millimeter
07RD-7110-22

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
DIASORIN MOLECULAR LLC
SC1100
In Commercial Distribution

  • 20816101025101 ()
SC1100

  • Optical laboratory instrument performance standard calibrator/control IVD, reusable
No Description
MAZOR ROBOTICS LTD
MAS1891-05S
In Commercial Distribution

  • 07290115750195 ()


  • Stereotactic surgery system probe, reusable
One-Piece Malleable (i-skin) Calf Panel for use with Motion Concepts CM Legrests. (Bendable/shape-able integral skin foam pad). One-Size only
Motion Concepts Inc
D-0101-0157-OPMCP
In Commercial Distribution

  • 07540147002480 ()
OPMCP

  • Wheelchair footrest/legrest
  • Wheelchair legrest pad
One-Piece Flat Calf Panel Mount Assy designed for use with Motion Concepts CM Legrests (includes mounting hardware). One-Piece Calf Pad sold separately. Available in a variety of widths and heights to accommodate different user needs.
Motion Concepts Inc
D-0101-0157-OSCPL
In Commercial Distribution

  • 07540147002473 ()
OSCPL

  • Wheelchair footrest/legrest
  • Wheelchair legrest pad
One-Piece Flat Calf Panel Pad use with Motion Concepts CM Legrests. (HR PU foam pad with black polyester fabric cover). Available in a variety of widths and heights to accommodate different user needs. Installs onto the corresponding sized One-Piece Calf Panel Assy.
Motion Concepts Inc
D-0197-OPFCP
In Commercial Distribution

  • 07540147002435 ()
OSFCP

  • Wheelchair footrest/legrest
  • Wheelchair legrest pad
No Description
Bracco Injeneering SA
650197
In Commercial Distribution

  • 37630039300112 ()
  • 17630039300118 ()
650197

  • Contrast medium injection system control unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV900
In Commercial Distribution

  • 06977717379900 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV6000
In Commercial Distribution

  • 06977717379627 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV600
In Commercial Distribution

  • 06977717379603 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV4500
In Commercial Distribution

  • 06977717379450 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV3600
In Commercial Distribution

  • 06977717379368 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV300
In Commercial Distribution

  • 06977717379306 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV2400
In Commercial Distribution

  • 06977717379245 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV200
In Commercial Distribution

  • 06977717379207 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV1500
In Commercial Distribution

  • 06977717379153 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV1000
In Commercial Distribution

  • 06977717379108 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV60
In Commercial Distribution

  • 06977717379061 ()


  • Red/infrared light phototherapy unit
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