Taiwan FDA registration cfa7ed56e58b5e96f0136786a2a49d60

Vitex biochemical product phencyclidine reagent

TW: 維特司生化產品苯環利定試劑

Taiwan·Risk Class 2·ORTHO-CLINICAL DIAGNOSTICS, INC.;; ORTHO-CLINICAL DIAGNOSTICS, INC·Registered May 14, 2009 – May 14, 2024Expired

Registration details

Analysis ID: cfa7ed56e58b5e96f0136786a2a49d60
Customs Code: DHA00602001103

Company information

Manufacturer: ORTHO-CLINICAL DIAGNOSTICS, INC.;; ORTHO-CLINICAL DIAGNOSTICS, INC
Manufacturer Country: United States
Authorized Representative: DKSH TAIWAN LTD.

Product details

Intended Use: The Vitex Phencyclidine Kit is used on the VITROS 5,1 FS Chemical Analyzer for semi-quantitative or qualitative determination of phencyclidine (PCP) in human urine using a cut-off value of 25 ng/mL.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.3100 Anandamide Test System
Import Information: import

Dates and status

Registration Date: May 14, 2009
Expiry Date: May 14, 2024

About this record

Access comprehensive regulatory information for Vitex biochemical product phencyclidine reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number cfa7ed56e58b5e96f0136786a2a49d60 and manufactured by ORTHO-CLINICAL DIAGNOSTICS, INC.;; ORTHO-CLINICAL DIAGNOSTICS, INC. The authorized representative in Taiwan is DKSH TAIWAN LTD..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.