Taiwan FDA registration 6bc4874ceff09bc3790e537b6ac9faff

BD Automated Liquid-Based Thin Layer Smear Preparation and Dyeing System

TW: BD自動液基薄層抹片製片染片系統
Taiwan flagTaiwan·Risk Class 3·Plexus Manufacturing Sdn. Bhd.;; BECTON DICKINSON AND COMPANY·Registered Oct 13, 2015 – Oct 13, 2025Expired
Registration details
Analysis ID
6bc4874ceff09bc3790e537b6ac9faff
Customs Code
DHA05602771604
Company information
Manufacturer Country
United States;;Malaysia
Product details
Intended Use
This product is a liquid-based, thin-layer cell preparation process, and the SurePath smear prepared with this product can be used to replace the traditional gynecological Pap smear. The SurePath smear can be used to screen and detect cervical cancer, precancerous lesions, atypical cells, and all other cytological classifications defined in the Bethesda System Cervical / Vaginal Cytology Diagnostic Classification Report.
Product Type (Level 1)
B Hematology, pathology, and genetics
Product Type (Level 2)
B.9999 Miscellaneous
Import Information
import
Dates and status
Registration Date
Oct 13, 2015
Expiry Date
Oct 13, 2025
About this record

Access comprehensive regulatory information for BD Automated Liquid-Based Thin Layer Smear Preparation and Dyeing System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 6bc4874ceff09bc3790e537b6ac9faff and manufactured by Plexus Manufacturing Sdn. Bhd.;; BECTON DICKINSON AND COMPANY. The authorized representative in Taiwan is BECTON DICKINSON HOLDINGS PTE. LTD. TAIWAN BRANCH (SINGAPORE).

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