Databa Updated May 5, 2005
Panel CFR Number Regulation Name/Device Name Class Ane sthe siology
1 868.5630 NEBULIZER
II 霧化治療器
Clinical Chemistry
2 862.1065AMMONIA TEST SYSTEM
I 氨測試系統
3 862.1113 BILIRUBIN (TOT AL AND UNBOUND) IN THE NEONATE TEST
I 新生兒膽紅素(總量及未結合的)試驗系統
4 862.1150 CALIBRATOR
II 比對標準品
5 862.1155 HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM
II 人類絨毛膜性腺激素
6 862.1160 BICARBONATE/CARBON DIOXIDE TEST SYSTEM
II 二氧化碳測試系統
7 862.1170 CHLORIDE TEST SYSTEM
II 氯化物試驗系統
8 862.1225 CREATININE TEST SYSTEM
II 肌氨酸酐試驗系統
9 862.1310 GALACTOSE TEST SYSTEM
I 半乳糖試驗系統
10 862.1340 URINARY GLUCOSE (NONQUANTIT ATIVE) TEST SYSTEM II
尿中血糖(非量化)測試系統
11 862.1345 GLUCOSE TEST SYSTEM
II 血糖測試系統
12 862.1410 IRON (NON-HEME) TEST SYSTEM
I 鐵(非原血紅素)測試系統
13 862.1415 IRON-BINDING CAPACITY TEST BINDING
I 鐵結合能力測試系統
14 862.1495 MAGNESIUM TEST SYSTEM
I 鎂測試系統
15 862.1580 PHOSPHORUS (INORGANIC) TEST SYSTEM
I 亞磷酸(無機)測試系統
16 862.1600 POT ASSIUM TEST SYSTEM
II 鉀測試系統
17 862.1660 QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAY)
I 品管物質(分析與非分析)
18 862.1665 SODIUM TEST SYSTEM
II 鈉測試系統
19 862.1680 TESTOSTERONE TEST SYSTEM
I 睪丸酮試驗系統
20 862.1730 FREE TYROSINE TEST SYSTEM
I 游離酥氨基酸試驗系統
21 862.1770UREA NITROGEN TEST SYSTEM
II 尿素測試系統
such22 862.1775URIC ACID TEST SYSTEM
I 尿酸測試系統
Cardiova scular
23 870.1120 BLOOD PRESSURE CUFF
II 壓脈帶式血壓計
24 870.1130 NONINVASIVE BLOOD PRESSURE MEASUREMENT
II 非侵入式血壓量測系統
25 870.2300 CARDIAC MONITOR (INCLUDING CARDIOT ACHOMETER
II 心臟監視器(心音、心跳警告功能)
26 870.2330 ECHOCARDIOGRAPH
II 超音波心臟照影計
27 870.2340 ELECTROCARDIOGRAPH
II 心電圖機
28 870.2350 ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR
II 心電圖導程切換接頭
29 870.2360 ELECTROCARDIOGRAPH ELECTRODE
II 心電圖機電極片
30 870.2370 ELECTROCARDIOGRAPH SURFACE ELECTRODE TESTER
II 心電圖用體表電極測試器
31 870.2880 ULTRASONIC TRANSDUCER
II 超音波換能器
Dental
32 872.1800 EXTRAORAL SOURCE X-RAY SYSTEM
II 口腔外X光機
33 872.1810 INTRAORAL SOURCE X-RAY SYSTEM
II 口腔內X光機
34 872.3200 RESIN TOOTH BONDING AGENT
II 樹脂牙黏著劑
35 872.3275 DENT AL CEMENT
II 牙科補泥
36 872.3660 IMPRESSION MATERIAL
II 牙模材料
37 872.3690TOOTH SHADE RESIN MATERIAL
II 補牙材料
38 870.3700 DENT AL MERCURY (U.S.P)
I 牙科用汞齊
39 872.4200 DENT AL HANDPIECES AND ACCESSORIES
I 牙科手持工具及附件
40 872.6250CHAIR WITH A UNIT
I 牙科用椅及附件
41 872.6640DENT AL OPERATIVE UNIT
I 牙科手術器械及附件
42 872.6710 BOILING WATER STERILIZER
I 沸水消毒鍋
Gastroenterology
43 876.1075 GASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT
american weddingII 腸胃科-泌尿科切片器械
44 876.1500 ENDOSCOPE AND ACCESSORIES
II 內視鏡及附件
45 876.4300 ENDOSCOPIC ELECTROSURGICAL UNIT AND
ACCESSORIES
II
內視鏡用電刀及其附件
46 876.4480 ELECTROHYDRAULIC LITHOTRIPTOR
电影铁娘子
II 水震波碎石機
47 876.4500 MECHANICAL LITHOTRIPTOR
II 機械碎石機
48 876.4620 URETERAL STENT
II 輸尿管支架
49 876.5010 BILIARY CATHETER AND ACCESSORIES
II 膽導管及附件
50 876.5130 UROLOGICAL CATHETER AND ACCESSORIES
II 泌尿導管及附件
51 876.5160 UROLOGICAL CLAMPS FOR MALES
I 男性尿道夾
52 876.5320 NONIMPLANTED ELECTRICAL CONTINENCE DEVICE
II 非植入式電子排尿自制器材
53 876.5665 WATER PURIFICATION SYSTEM FOR DIALYSIS
II 血液透析用的水淨化系統
General Hospital
54 880.2910 CLINICAL ELECTRONIC THERMOMETER
II 電子式體溫計
55880.5200 INTRAVASCULAR CATHETER
II 血管內導管
56880.5400 NEONAT AL INCUBATOR
II 新生兒保溫箱
57880.5410 NEONAT AL TRANSPORT INCUBATOR
II 可攜式新生兒保溫箱
58 880.5440 INTRAVASCULAR ADMINISTRATION SET儿歌网址
II 血管內輸液套
59 880.5570 HYPODERMIC SINGLE LUMEN NEEDLE
II 皮下注射單管腔針頭
60 880.5680 PEDIATRIC POSITION HOLDER
I 小兒姿勢固定器
61880.5725 INFUSION PUMP
II 輸液幫浦
月份英文62880.5860 PISTON SYRINGE
II 注射針筒
alacrity
63 880.6250PATIENT EXAMINATION GLOVE
I 醫檢手套
64 880.6375 PATIENT LUBRICANT
I 病患用潤滑劑
65 880.6760 PROTECTIVE RESTRAINT
someone like you 什么意思I 保護性限制束帶
66 880.6880 STEAM STERILIZER
II 蒸氣消毒鍋
67880.6885LIQUID CHEMICAL STERILANTS/HIGH LEVEL
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DISINFECT ANTS II 化學液體滅菌劑
Microbiology
Same as
17862.1660
QUALITY CONTROL MATERIAL (ASSAYED AND
UNASSAYED) I
品管工具(分析與非分析)
68866.1620ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
II 抗菌感受性試驗盤
69866.1640ANTIMICROBIAL SUSCEPTIBILITY TEST POWDER
II 抗菌感受性試驗粉末
70866.2390TRANSPORT CULTURE MEDIUM
I 輸送培養基
71866.2560MICROBIAL GROW TH MONITOR
I 微生物生長監視器六级考试报名
72866.2850AUTOMATED ZONE READER
I 自動區域判讀器
73866.2900MICROBIOLOGICAL SPECIMEN COLLECTION AND TRANSPORT DEVICE I 微生物樣本收集及輸送器材
74866.3110CAMPYLOBACTER FETUS SEROLOGICAL REAGENTS
I 胎兒彎曲畸形菌屬血清試劑
75866.3120CHLAMYDIA SEROLOGICAL REAGENTS
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I 披衣菌血清試劑
