Taiwan FDA registration 9f0934f1b4d2a4d98f2ba6da162f7775

ABBOTT ARCHITECT 2nd Generation Testosterone Reagent Kit(Non-Sterile)

TW: 亞培設計師第二代睪丸脂酮試劑組(未滅菌)

Taiwan·Risk Class 1·MD·Axis-Shield Diagnostics Limited·Registered Dec 20, 2018 – Dec 20, 2028Active

Registration details

Analysis ID: 9f0934f1b4d2a4d98f2ba6da162f7775
License Form: Ministry of Health Medical Device Import No. 019937
Customs Code: DHA09401993705

Company information

Manufacturer: Axis-Shield Diagnostics Limited
Manufacturer Country: United Kingdom
Authorized Representative: ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)

Product details

Intended Use: Limited to the first level identification range of the "testicular lipoketone test system (A.1680)" of the Measures for the Administration of Medical Equipment.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A1680 Testicular Lipoketone Test System
Import Information: Imported from abroad

Dates and status

Registration Date: Dec 20, 2018
Expiry Date: Dec 20, 2028

About this record

Access comprehensive regulatory information for ABBOTT ARCHITECT 2nd Generation Testosterone Reagent Kit(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 9f0934f1b4d2a4d98f2ba6da162f7775 and manufactured by Axis-Shield Diagnostics Limited. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

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