Taiwan FDA registration eb57a6bc77932c3bc22f8de1a46bf12f

Rotavirus Antigen Rapid Test Reagent (Unsterilized)

TW: “艾快露”輪狀病毒抗原快速檢驗試劑 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·ACRO BIOTECH INC.·Registered Sep 10, 2016 – Sep 10, 2026Active
Registration details
Analysis ID
eb57a6bc77932c3bc22f8de1a46bf12f
Customs Code
DHA09401699201
Company information
Manufacturer
ACRO BIOTECH INC.
Manufacturer Country
United States
Authorized Representative
Grand Marquis IVD CO., LTD.
Product details
Intended Use
It is limited to the first level of identification scope of the "Poliovirus Serum Reagent (C.3405)" of the Measures for the Classification and Grading of Medical Devices.
Product Type (Level 1)
C Immunology and microbiology
Product Type (Level 2)
C.3405 Poliomyelitis virus serum reagent
Import Information
import
Dates and status
Registration Date
Sep 10, 2016
Expiry Date
Sep 10, 2026
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About this record

Access comprehensive regulatory information for Rotavirus Antigen Rapid Test Reagent (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number eb57a6bc77932c3bc22f8de1a46bf12f and manufactured by ACRO BIOTECH INC.. The authorized representative in Taiwan is Grand Marquis IVD CO., LTD..

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including FIRSTEP BIORESEARCH INC., Asia Genomics Technology Co., Ltd. Factory 1, and 2 recent registrations in the same category. 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.

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