Taiwan FDA registration 18456131bac98e39e16e2fbb2af336dd
Gen-Probe APTIMA Trichomonas vaginalis Assay
TW: 基譜艾緹瑪陰道滴蟲檢測套組
Taiwan·Risk Class 2·MD·Hologic, Inc.·Registered Nov 17, 2015 – Nov 17, 2025ExpiredRegistration details
- Analysis ID
- 18456131bac98e39e16e2fbb2af336dd
- License Form
- Ministry of Health Medical Device Import No. 027911
- Customs Code
- DHA05602791102
Company information
- Manufacturer
- Hologic, Inc.
- Manufacturer Country
- United States
- Authorized Representative
- QUALTECH CONSULTING CORPORATION
Product details
- Intended Use
- In conjunction with the PANTHER detection system, in vitro qualitative nucleic acid amplification test (NAAT) is used to diagnose vaginal trichomoniasis against vaginal trichomonas ribosomon RNA (rRNA).
- Product Type (Level 1)
- C Immunology and microbiology devices
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Nov 17, 2015
- Expiry Date
- Nov 17, 2025
About this record
Access comprehensive regulatory information for Gen-Probe APTIMA Trichomonas vaginalis Assay in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 18456131bac98e39e16e2fbb2af336dd and manufactured by Hologic, Inc.. The authorized representative in Taiwan is QUALTECH CONSULTING CORPORATION.
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