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["附件一"]
[]
["醫療器材分類:"]
["（CATEGORIES）"]
["     一、臨床化學及臨床毒理學"]
["              （CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES）"]
["     二、血液學及病理學"]
["              （HEMATOLOGY AND PATHOLOGY DEVICES）"]
["     三、免疫學及微生物學  "]
["              （IMMUNOLOGY AND MICROBIOLOGY DEVICES ）"]
["     四、麻醉學"]
["              （ANESTHESIOLOGY DEVICES）"]
["     五、心臟血管醫學"]
["              （CARDIOVASCULAR DEVICES）"]
["     六、牙科學"]
["              （DENTAL DEVICES）"]
["     七、耳鼻喉科學"]
["              （EAR, NOSE, AND THROAT DEVICES）"]
["     八、胃腸病科學及泌尿科學"]
["              （GASTROENTEROLOGY-UROLOGY DEVICES）"]
["     九、一般及整形外科手術"]
["              （GENERAL AND PLASTIC SURGERY DEVICES）"]
["     十、一般醫院及個人使用裝置"]
["              （GENERAL HOSPITAL AND PERSONAL USE DEVICES）"]
["     十一、神經科學"]
["              （NEUROLOGICAL DEVICES）"]
["     十二、婦產科學"]
["              （OBSTETRICAL AND GYNECOLOGICAL DEVICES）"]
["     十三、眼科學"]
["              （OPHTHALMIC DEVICES）"]
["     十四、骨科學"]
["              （ORTHOPEDIC DEVICES）"]
["     十五、物理醫學科學"]
["              （PHYSICAL MEDICINE DEVICES）"]
["     十六、放射學科學"]
["              （RADIOLOGY DEVICES）"]
["     十七、其他經中央衛生主管機關認定者"]
["               (OTHER CATEGORIES SPECIFIED BY THE CENTRAL COMPETENT HEALTH AUTHORITY)"]

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["三、","免疫學及微生物學裝置"]
[null,"(IMMUNOLOGY AND MICROBIOLOGY DEVICES)"]
["代碼","名稱","鑑別","等級"]
["C.3305　","單純皰疹病毒血清分析(Herpes simplex virus serological assay)","單純皰疹病毒(herpes simples virus)血清試劑含抗原及抗血清，用於血清試驗中鑑定對血清中單純皰疹病毒的抗體。另外，這些試劑有些含抗血清結合螢光染料(免疫螢光試劑)，可直接由臨床樣本中鑑定此病毒或其培養基中將單純皰疹病毒分離出來。有助於診斷此病毒引起的疾病並提供此病的流行病學資料。單純皰疹病毒感染的範圍由感冒、輕微皮膚及黏膜損害到嚴重的腦膜炎(腦部發炎)。新生兒單純皰疹病毒感染則由輕微的感染到嚴重的廣泛性致死疾病均有。(1) 若此器材使用於鑑定HSV 1 及/或 2，則屬於第二等級醫療器材。 (2) 當試劑使用於鑑定HSV其他型別，則屬於第三等級醫療器材。","2,3"]