Alternative names
Real Time Polymerase Chain Reaction (RT-PCR); PCR thermal cycler
Primary use
Type of medical device or related product
Multiple vs. specific use (health condition)
Intended population age
Intended population sex
Level of technical knowledge
Capital
Reusable
Requirements
None
WHO list of priority medical devices
Service delivery platforms / Healthcare levels
Healthcare unit
EMDN related code(s)
W020501
Nucleic acid testing instruments except micro-arrays
The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities.
Please consult your regulatory agency and EMDN site:
https://webgate.ec.europa.eu/dyna2/emdn
GMDN related code(s)
48031
Thermal cycler nucleic acid amplification analyser IVD, laboratory (An electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or identified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification.)
The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO.
As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult
https://gmdnagency.org
GMDN ®. © GMDN Agency 2005-2025
WHO Technical specifications
WHO related resources
WHO resources on medical devices
Interagency list of priority medical devices for essential interventions for reproductive, maternal, newborn and
child health
WHO list of priority medical devices for cancer management
WHO List of Priority Medical Devices for management of cardiovascular diseases and diabetes
WHO List of Priority medical devices list for the COVID-19 response and associated technical specifications
Package of eye care interventions
Trauma and Emergency Surgery Kit (TESK) 2019
WHO medical devices website
WHO priority medical devices website
WHO essential in vitro diagnostic website
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Qualitative HIV nucleic acid amplification test
Quantitative HBV nucleic acid amplification test
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SARS-CoV-2 nucleic acid amplification test
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