Taiwan FDA registration 9f3cc6d6fc81f2e706ed55c586a02025

Innova rheumatoid factor immunoglobulin M chemical cold light immunoassay reaction reagent

TW: 因諾瓦類風濕因子免疫球蛋白M化學冷光免疫分析法反應試劑

Taiwan·Risk Class 2·INOVA Diagnostics, Inc·Registered Apr 28, 2020 – Apr 28, 2025Expired

Registration details

Analysis ID: 9f3cc6d6fc81f2e706ed55c586a02025
Customs Code: DHA05603347609

Company information

Manufacturer: INOVA Diagnostics, Inc
Manufacturer Country: United States
Authorized Representative: TRUGENE DIAGNOSTICS, INC.

Product details

Intended Use: This product uses chemical cold light immunoassay to quantitatively detect anti-rheumatoid factor immunoglobulin M antibodies in human serum samples.
Product Type (Level 1): A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
Product Type (Level 2): C.5775 Hydrogenic factor immunoassay system;; A.1660 Grade Material (Analysis Material Non-Analysis);; A.1150 Calibrated Products
Import Information: import

Dates and status

Registration Date: Apr 28, 2020
Expiry Date: Apr 28, 2025

About this record

Access comprehensive regulatory information for Innova rheumatoid factor immunoglobulin M chemical cold light immunoassay reaction reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9f3cc6d6fc81f2e706ed55c586a02025 and manufactured by INOVA Diagnostics, Inc. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..

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