Is the device intended to be used for any of the following purposes?

 
red-blood-cells.jpg
  • detection of the presence of, or exposure to, a transmissible agent in blood, blood components, cells, tissues or organs, or in any of their derivatives, in order to assess their suitability for transfusion, transplantation or cell administration;

  • detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation;

  • determining the infectious load of a life-threatening disease where monitoring is critical in the process of patient management.

 

Is your device intended to be used for blood grouping, or to determine foeto-maternal blood group incompatibility, or for tissue typing to ensure the immunological compatibility of blood, ◄ blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration?

SebastianKaulitzki.jpg
 

Is your device intended to to determine any of the following markers?

p22-23-duffy-diagram-.jpeg

  • ABO system [A (ABO1), B (ABO2), AB (ABO3)];

  • Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)];

  • Kell system [Kel1 (K)];

  • Kidd system [JK1 (Jka), JK2 (Jkb)];​

  • Duffy system [FY1 (Fya), FY2 (Fyb)];

 

Is your device intended for any of the following?

1317_CFS_Circulation.jpeg
  1. ​for detecting the presence of, or exposure to, a sexually transmitted agent;

  2. for detecting the presence in cerebrospinal fluid or blood of an infectious agent without a high or suspected high risk of propagation;

  3. for detecting the presence of an infectious agent, if there is a significant risk that an erroneous result would cause death or severe disability to the individual, foetus or embryo being tested, or to the individual's offspring;

  4. for pre-natal screening of women in order to determine their immune status towards transmissible agents;

  5. for determining infective disease status or immune status, where there is a risk that an erroneous result would lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient's offspring;

  6. to be used as companion diagnostics;

  7. to be used for disease staging, where there is a risk that an erroneous result would lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient's offspring;

  8. to be used in screening, diagnosis, or staging of cancer;

  9. for human genetic testing;

  10. for monitoring of levels of medicinal products, substances or biological components, when there is a risk that an erroneous result will lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient's offspring;

  11. for management of patients suffering from a life-threatening disease or condition;

  12. for screening for congenital disorders in the embryo or foetus;

  13. for screening for congenital disorders in new-born babies where failure to detect and treat such disorders could lead to life-threatening situations or severe disabilities.

 

Is your device intended for self-testing?

Drug-of-Abuse-Products-1.jpeg
 

Is your device intended for the detection of pregnancy, for fertility testing and/or for determining cholesterol level, and/or devices for the detection of glucose, erythrocytes, leucocytes and bacteria in urine?

Amazing-d-Tech-Continuous-Glucose-Monito
 

Is your device intended for near-patient testing?

TestDevelopment.webp

Is your device one of the following?

 
A_S.jpeg
  1. products for general laboratory use, accessories which possess no critical characteristics, buffer solutions, washing solutions, and general culture media and histological stains, intended by the manufacturer to make them suitable for in vitro diagnostic procedures relating to a specific examination

  2. instruments intended by the manufacturer specifically to be used for in vitro diagnostic procedures

  3. specimen receptacles

Is your device a control without a quantitative or qualitative assigned value?

 
active device.jpeg