Taiwan FDA registration 7eeed84cc032a620e5e116cd95a9e944

Roche immunoassay anti-Mullerian hormonal test reagent

TW: 羅氏免疫分析抗穆勒氏管賀爾蒙檢驗試劑
Taiwan flagTaiwan·Risk Class 2·ROCHE DIAGNOSTICS GMBH·Registered May 28, 2015 – May 28, 2020Cancelled
Registration details
Analysis ID
7eeed84cc032a620e5e116cd95a9e944
Customs Code
DHA05602734304
Company information
Manufacturer Country
Germany
Authorized Representative
ROCHE DIAGNOSTICS LTD.
Product details
Intended Use
本產品利用電化學發光免疫分析法,搭配Elecsys 2010、cobas e411、MODULAR ANALYTICS E170、coabs e 601、cobas e 602免疫分析儀,體外定量檢測人類血清和血漿中的抗穆勒氏管賀爾蒙.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration
Import Information
import
Dates and status
Registration Date
May 28, 2015
Expiry Date
May 28, 2020
Cancellation Date
May 19, 2022
Cancellation information
Status
Logged out
Reason
自行鍵入
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About this record

Access comprehensive regulatory information for Roche immunoassay anti-Mullerian hormonal test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7eeed84cc032a620e5e116cd95a9e944 and manufactured by ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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