By: Cindy Lazo
– In Vitro Diagnostic Agents (IVD):
May be a reagent, calibrator, control material or kit, used alone or in combination. Intended by the manufacturer to be used in vitro for the study of samples from the human body.
Examples:
- Glucose test strips
- Pregnancy tests
– Computer systems for medical use:
Software intended to be used for one or more medical purposes and that does not require to be part of hardware classified as a medical device to fulfill its function.
Examples:
- Software that analyzes heart rate
- Image archiving and communication system
– Antiseptic and disinfectant products for hospital medical use:
These are products intended for the disinfection of other medical devices and those intended for the antisepsis of the skin or mucous membranes, prior to a surgical procedure or the antisepsis of some wounds.
Examples:
- Hydrogen peroxide
- Chlorhexidine solution
– Other medical devices.
This category includes all medical devices other than in vitro diagnostic agents, medical computer systems, antiseptics and disinfectants for hospital medical use.
Examples:
- Thermometer
- Surgical masks
- Dental cement
- Bone cement, (among others).