Taiwan FDA registration cc7cf5bd65e9a65b8a9f126a947d41f5

LANNER Homocysteine (Enzymatic Cycling Method) Reagent Kit / HCYc

TW: 朕江同半胱胺酸(循環酶法)試劑套組

Taiwan·Risk Class 2·MD·LANNER BIOTECHNOLOGY CO., LTD.·Registered Sep 09, 2016 – Sep 09, 2026Active

Registration details

Analysis ID: cc7cf5bd65e9a65b8a9f126a947d41f5
License Form: Ministry of Health Medical Device Manufacturing No. 005342

Company information

Manufacturer: LANNER BIOTECHNOLOGY CO., LTD.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: LANNER BIOTECHNOLOGY CO., LTD.

Product details

Intended Use: It is used for in vitro quantitative analysis of homocysteine content in human serum or plasma, and is suitable for Xujiang T900 automatic biochemical analyzer. Clinically, homocysteine measurement is used to diagnose homocystinuria, identify vitamin B12 or folate deficiency, and assess risk factors for cardiovascular disease (CVD) and other diseases.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A1377 Urinary cystine non-quantitative test system
Import Information: Produced in Taiwan, China

Dates and status

Registration Date: Sep 09, 2016
Expiry Date: Sep 09, 2026

About this record

Access comprehensive regulatory information for LANNER Homocysteine (Enzymatic Cycling Method) Reagent Kit / HCYc in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number cc7cf5bd65e9a65b8a9f126a947d41f5 and manufactured by LANNER BIOTECHNOLOGY CO., LTD.. The authorized representative in Taiwan is LANNER BIOTECHNOLOGY CO., LTD..

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