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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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Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.
LUMINEX CORPORATION
3803-21
In Commercial Distribution

  • 00840487101186 ()
3803-21

  • Endogenous RNA internal control reagent IVD
Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.
LUMINEX CORPORATION
3803
In Commercial Distribution

  • 00840487101179 ()
3803

  • Endogenous RNA internal control reagent IVD
Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.
LUMINEX CORPORATION
3802-21
Not in Commercial Distribution

  • 00840487101162 ()
3802-21

  • Endogenous RNA internal control reagent IVD
Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.
LUMINEX CORPORATION
3802
In Commercial Distribution

  • 00840487101155 ()
3802

  • Endogenous RNA internal control reagent IVD
Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.
LUMINEX CORPORATION
3695-21
Not in Commercial Distribution

  • 00840487101148 ()
3695-21

  • Endogenous RNA internal control reagent IVD
Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.
LUMINEX CORPORATION
3695
Not in Commercial Distribution

  • 00840487101131 ()
3695

  • Endogenous RNA internal control reagent IVD
DBD-DETECTOR,CO2,PEDIATRIC
MEDLINE INDUSTRIES, INC.
HCSCO2P
In Commercial Distribution

  • 20888277660189 ()
  • 10888277660182 ()
HCSCO2P

  • Ultrasonic nebulizing system
  • Resuscitator face mask, single-use
The Algometer provides pain diagnostic testing with digital clarity and computer interface for data logging. The AlgoMed Computerized Pressure Algometry is an Algometry device including advanced software package designed for clinical use and advance research in the field of Pain Management. The AlgoMed enables the user to perform various pressure test paradigms including the method of limits and the ramp and hold method. These test paradigms can be utilized for a wide range of pressure pain measures such as pressure pain threshold and tolerance, temporal summation, DNIC and more. The device can also evaluate disease or treatment progress over time.
MEDOC LTD.
FPIX
In Commercial Distribution

  • 07290103039554 ()
  • 07290103039059 ()
AS 00300

  • Pressure algesimeter
The Annidis RHA2020-U multi-spectral digital ophthalmoscope is intended to capture images of the fundus of the eye which can be used to assist in diagnosis and observation of fundus diseases.
Annidis Health Systems Corp
RHA2020/2020-U
Not in Commercial Distribution

  • 00627843652021 ()


  • Direct ophthalmoscope, line-powered
The F-10 captures and records the confocal images of fundus by laser scanning using a selection of laser colors: IR (infrared), blue, green, and red. Indocyanine green (ICG) angiography and fluorescein angiography (FAG) are also possible.
NIDEK CO.,LTD.
F-10
In Commercial Distribution

  • 04987669100561 ()


  • Direct ophthalmoscope, line-powered
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