Taiwan FDA registration 97c6409d1409c7f6a0b527a32060a386

Wuding microalbumin/creatinine ratio reagent cassette

TW: 五鼎微量白蛋白/肌酸酐比值試劑卡匣

Taiwan·Risk Class 2·APEX BIOTECHNOLOGY CORPORATION·Registered Nov 02, 2023 – Nov 02, 2028Active

Registration details

Analysis ID: 97c6409d1409c7f6a0b527a32060a386

Company information

Manufacturer: APEX BIOTECHNOLOGY CORPORATION
Manufacturer Country: Taiwan, Province of China
Authorized Representative: APEX BIOTECHNOLOGY CORPORATION

Product details

Intended Use: This product is used with a Wuding four-in-one multi-function analyzer to quantitatively detect the microalbumin/creatinine concentration ratio in human urine.
Product Type (Level 1): C Immunology and Microbiology; A Clinical chemistry and clinical toxicology
Product Type (Level 2): C.5040 白蛋白免疫試驗系統;; A.1225 肌氨酸酐試驗系統(Creatininetestsystem)
Import Information: QMS/QSD;; 國產

Dates and status

Registration Date: Nov 02, 2023
Expiry Date: Nov 02, 2028

About this record

Access comprehensive regulatory information for Wuding microalbumin/creatinine ratio reagent cassette in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 97c6409d1409c7f6a0b527a32060a386 and manufactured by APEX BIOTECHNOLOGY CORPORATION. The authorized representative in Taiwan is APEX BIOTECHNOLOGY CORPORATION.

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