Taiwan FDA registration 11ca03427bae4b6e2f740ddbd0c5afd8

"ACRO BIOTECH" Strep A Rapid Test (Non-Sterile)

TW: "愛可羅" A型鏈球菌試劑(未滅菌)

Taiwan·Risk Class 1·MD·ACRO BIOTECH INC.·Registered Feb 12, 2020 – Feb 12, 2025Expired

Registration details

Analysis ID: 11ca03427bae4b6e2f740ddbd0c5afd8
License Form: Ministry of Health Medical Device Import No. 021251
Customs Code: DHA09402125102

Company information

Manufacturer: ACRO BIOTECH INC.
Manufacturer Country: United States
Authorized Representative: APPLIED BIOTECH ENTERPRISE CO., LTD.

Product details

Intended Use: Restriction of medical device management methods Streptococcus belongs to the first level identification range of serum reagent (C.3740).
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C3740 Streptococcus serology
Import Information: Imported from abroad

Dates and status

Registration Date: Feb 12, 2020
Expiry Date: Feb 12, 2025

About this record

Access comprehensive regulatory information for "ACRO BIOTECH" Strep A Rapid Test (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 11ca03427bae4b6e2f740ddbd0c5afd8 and manufactured by ACRO BIOTECH INC.. The authorized representative in Taiwan is APPLIED BIOTECH ENTERPRISE CO., LTD..

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