Taiwan FDA registration ae3df04bf2b4c6a5ae77bae58b6f4d0d

"Side" biological type A fetal protein detection plate

TW: 「司德」生物類甲型胎兒蛋白檢測盤

Taiwan·Risk Class 2·STANDARD DIAGNOSTICS, INC.·Registered Dec 25, 2007 – Dec 25, 2012Cancelled

Registration details

Analysis ID: ae3df04bf2b4c6a5ae77bae58b6f4d0d
Customs Code: DHA00601870202

Company information

Manufacturer: STANDARD DIAGNOSTICS, INC.
Manufacturer Country: Korea, Republic of
Authorized Representative: LINKSEAS TRADING CO., LTD.

Product details

Intended Use: THE SD BIOLINE AFP ASSAY DISC IS AN IN VITRO IMMUNOCHROMATOGRAPHIC ASSAY DESIGNED FOR THE RAPID AND QUALITATIVE DETECTION OF AFP IN HUMAN SERUM OR PLASMA.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.6010 腫瘤相關抗原免疫試驗系統
Import Information: import

Dates and status

Registration Date: Dec 25, 2007
Expiry Date: Dec 25, 2012
Cancellation Date: Jun 12, 2014

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

Access comprehensive regulatory information for "Side" biological type A fetal protein detection plate in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number ae3df04bf2b4c6a5ae77bae58b6f4d0d and manufactured by STANDARD DIAGNOSTICS, INC.. The authorized representative in Taiwan is LINKSEAS TRADING CO., LTD..

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