此產品是否作一般化驗用途但非製造、售賣或代表作指定體外診斷應用?
此體外診斷醫療儀器作為對照物,是否沒有質量值及數量值?
此體外診斷醫療儀器是否擬用於檢測血液、血液成分、血液衍生物、細胞、組織或器官是否含有或曾接觸傳染性病原體,以評估是否適合進行輸血或移植?
此體外診斷醫療儀器是否擬用於檢測是否含有或曾接觸可引致傳播風險甚高、致命及通常難以治癒疾病的傳染性病原體?
此體外診斷醫療儀器是否擬用作確定ABO系統[A(ABO1)、B(ABO2)、AB(ABO3)]、獼猴(Rh)系統[RH1(D)、RH2(C)、RH3(E)、RH4(c)、RH5(e)]、Kell系統[Kel1(K)]、Kidd系統[JK1(Jka)、JK2(Jkb)]和Duffy系統[FY1(Fya)、FY2(Fyb)]?
此體外診斷醫療儀器是否擬用作血型檢定或組織分型,以確保擬作輸血或移植用的血液、血液成分、細胞、組織或器官在免疫方面相容?
此體外診斷醫療儀器是否擬用以檢測是否含有或曾接觸性病傳染性病原體?
此體外診斷醫療儀器是否擬用以檢測腦脊髓液或血液是否含有傳播風險有限的傳染性病原體?
此體外診斷醫療儀器是否擬用以檢測是否含有傳染性病原體,而得出錯誤結果有引致接受測試人士或胎兒死亡或嚴重傷殘的重大風險?
此體外診斷醫療儀器是否擬用作婦女產前檢查,以決定其對傳染性病原體的免疫狀況?
此體外診斷醫療儀器是否擬用以決定傳染性疾病狀況或免疫狀況,而得出錯誤結果有導致作出會令患者生命受到迫切威脅的治理決定的風險?
此體外診斷醫療儀器是否擬用以篩選患者進行選擇性治療和治理,或用作疾病分期或用作癌症診斷?
在使用此體外診斷醫療儀器後,並為治療作出決定前,是否需作進一步調查? 以及此體外診斷醫療儀器是否擬用以監察?
此體外診斷醫療儀器是否擬用作人類基因測試?
此體外診斷醫療儀器是否擬用以監察藥物、物質或生物成分的水平,而得出錯誤結果有導致作出令患者生命受到即時威脅的治理決定的風險?
此體外診斷醫療儀器是否擬用以治理患有致命傳染病的患者?
此體外診斷醫療儀器是否擬用以普查胎兒的先天障礙?
此體外診斷醫療儀器是否擬用作自行測試?
該等體外診斷醫療儀器所得結果是否能決定醫學上的危急情況?
該等體外診斷醫療儀器所得結果是否屬於初步結果,並須進行適當實驗室化驗等跟進措施?
此體外診斷醫療儀器是否擬在近患者測試決定血液氣體和血糖狀況?
此體外診斷醫療儀器是否具指定特徵、製造商擬用作有關指定檢驗的體外診斷程序試劑或其他物品?
此體外診斷醫療儀器是否製造商擬專門用作體外診斷程序的器材?
此體外診斷醫療儀器是否樣本盛器?
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?
此儀器並不屬於體外診斷醫療儀器。
上述醫療儀器分級程式的結果僅供參考。由於醫療行政管理制度的涵蓋範圍會不時更新,因此醫療儀器的實際分級亦會有所更改。程式設計者及網頁管理員均不會對此分級程式結果的準確性負上或承擔任何法律責任。