此产品是否作一般化验用途但非制造、售卖或代表作指定体外诊断应用?
此体外诊断医疗仪器作为对照物，是否没有质量值及數量值?
此体外诊断医疗仪器是否拟用于检测血液、血液成分、血液衍生物、细胞、组织或器官是否含有或曾接触传染性病原体，以评估是否适合进行输血或移植?
此体外诊断医疗仪器是否拟用于检测是否含有或曾接触可引致传播风险甚高、致命及通常难以治癒疾病的传染性病原体?
此体外诊断医疗仪器是否拟用作确定ABO系统[A(ABO1)、B(ABO2)、AB(ABO3)]、猕猴(Rh)系统[RH1(D)、RH2(C)、RH3(E)、RH4(c)、RH5(e)]、Kell系统[Kel1(K)]、Kidd系统[JK1(Jka)、JK2(Jkb)]和Duffy系统[FY1(Fya)、FY2(Fyb)]?
此体外诊断医疗仪器是否拟用作血型检定或组织分型，以确保拟作输血或移植用的血液、血液成分、细胞、组织或器官在免疫方面相容?
此体外诊断医疗仪器是否拟用以检测是否含有或曾接触性病传染性病原体?
此体外诊断医疗仪器是否拟用以检测脑脊髓液或血液是否含有传播风险有限的传染性病原体?
此体外诊断医疗仪器是否拟用以检测是否含有传染性病原体，而得出错误结果有引致接受测试人士或胎儿死亡或严重伤残的重大风险?
此体外诊断医疗仪器是否拟用作妇女产前检查，以决定其对传染性病原体的免疫狀况?
此体外诊断医疗仪器是否拟用以决定传染性疾病狀况或免疫狀况，而得出错误结果有导致作出会令患者生命受到迫切威胁的治理决定的风险?
此体外诊断医疗仪器是否拟用以筛选患者进行选择性治療和治理，或用作疾病分期或用作癌症诊断?
在使用此体外诊断医疗仪器后，并为治療作出决定前，是否需作进一步调查? 以及此体外诊断医疗仪器是否拟用以监察?
此体外诊断医疗仪器是否拟用作人類基因测试?
此体外诊断医疗仪器是否拟用以监察药物、物质或生物成分的水平，而得出错误结果有导致作出令患者生命受到即时威胁的治理决定的风险?
此体外诊断医疗仪器是否拟用以治理患有致命传染病的患者?
此体外诊断医疗仪器是否拟用以普查胎儿的先天障碍?
此体外诊断医疗仪器是否拟用作自行测试?
该等体外诊断医疗仪器所得结果是否能决定医学上的危急情况?
该等体外诊断医疗仪器所得结果是否属于初步结果，并须进行适当实验室化验等跟进措施?
此体外诊断医疗仪器是否拟在近患者测试决定血液气体和血糖狀况?
此体外诊断医疗仪器是否具指定特征、制造商拟用作有关指定检验的体外诊断程序试剂或其他物品?
此体外诊断医疗仪器是否制造商拟专门用作体外诊断程序的器材？
此体外诊断医疗仪器是否样本盛器?
Does this device require any procedure that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode and route of administration?
Is this device come into contact with injured skin?
Is this device intended to be used principally with wounds which have breached the dermis?
Is this device intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent?
Is this device intended for channeling or storing body liquids or tissues, liquids or gases?
Is this a blood bag?
Can this device be connected to an active device in Class II or a higher class?
Is this device intended for channeling or storing body liquids or tissues, liquids, or gases for the purpose of eventual infusion, administration or introduction into the body?
Is this device intended for modifying the biological or chemical composition of blood, other body liquids, or other liquids intended for infusion into the body?
Does the treatment of this device consist of filtration, centrifuging or exchanges of gas or of heat?
Is this device invasive with respect to body orifices (other than those which are surgically invasive)?
Is this device intended to be connected to an active medical device in Class II or a higher class?
Is this device intended to be placed into the teeth?
Is this device intended to undergo chemical change in the body (except if the devices are placed in the teeth)?
Is this device intended to have a biological effect or be wholly or mainly absorbed?
Is this a breast implant?
Is this device intended to be an active implantable medical device?
Is this device intended to be life supporting or life sustaining?
Is this device intended to supply energy in the form of ionizing radiation?
Is this a reusable surgical instrument (other than those in Class IV)?
Is this device intended to be connected to an active medical device ?
Is this device supplied sterile and intended for single use?
此仪器并不属于体外诊断医疗仪器。
上述医疗仪器分级程式的结果仅供参考。由于医疗行政管理制度的涵盖范围会不时更新，因此医疗仪器的实际分级亦会有所更改。程式设计者及网页管理员均不会对此分级程式结果的准确性负上或承担任何法律责任。