Taiwan FDA registration 2e89caaea485cd0bf50d0e2b24e0de38

Homocysteine reagents for vitex biochemical products

TW: 維特司生化產品同型半胱氨酸試劑
Taiwan flagTaiwan·Risk Class 2·ORTHO-CLINICAL DIAGNOSTICS, INC.;; ORTHO-CLINICAL DIAGNOSTICS, INC·Registered May 04, 2009 – May 04, 2014Cancelled
Registration details
Analysis ID
2e89caaea485cd0bf50d0e2b24e0de38
Customs Code
DHA00602000100
Company information
Manufacturer Country
United States
Product details
Intended Use
For the quantitative determination of total concentrations of homocysteine (HCY) in human serum and plasma. Homocysteine concentrations in serum and plasma can help diagnose and treat homocysteinemia and homocystinuria.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1377 Cystine-like non-quantitative testing system in urine
Import Information
import
Dates and status
Registration Date
May 04, 2009
Expiry Date
May 04, 2014
Cancellation Date
Sep 26, 2016
Cancellation information
Status
Logged out
Reason
許可證已逾有效期
About this record

Access comprehensive regulatory information for Homocysteine reagents for vitex biochemical products in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 2e89caaea485cd0bf50d0e2b24e0de38 and manufactured by ORTHO-CLINICAL DIAGNOSTICS, INC.;; ORTHO-CLINICAL DIAGNOSTICS, INC. The authorized representative in Taiwan is Yingshang Zhuangsheng and Zhuangsheng (Hong Kong) Co., Ltd. Taiwan Branch.

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