Taiwan FDA registration 3ca0e73d8176d4c2579afe35cc995375
Konya Rheumatoid Factor Reagent
TW: 科尼亞類風濕因子試劑
Taiwan·Risk Class 2·KAMIYA BIOMEDICAL COMPANY·Registered Mar 05, 2010 – Mar 05, 2020CancelledRegistration details
- Analysis ID
- 3ca0e73d8176d4c2579afe35cc995375
- Customs Code
- DHA00602083905
Company information
- Manufacturer
- KAMIYA BIOMEDICAL COMPANY
- Manufacturer Country
- United States
- Authorized Representative
- TUNYEN ENTERPRISE CORPORATION
Product details
- Intended Use
- Immunotrubidimetric assay was used to quantitatively determine the rheumatoid factor in human serum. Rheumatoid factor is a type of immune antibody that is present in the patient's serum and reacts with the aggregate properties of IgG contained in the reagent to form immune complexes. The amount of immune complexes produced is directly proportional to the concentration of rheumatoid factor in the serum. Rheumatoid factor can be found in the serum of about 50-79% of typical rheumatoid arthritis, showing that the concentration of rheumatoid factor in the quantitative serum can effectively diagnose and predict rheumatoid arthritis in clinical practice.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.5775 類風濕性因子免疫試驗系統
- Import Information
- import
Dates and status
- Registration Date
- Mar 05, 2010
- Expiry Date
- Mar 05, 2020
- Cancellation Date
- Apr 08, 2020
Cancellation information
- Status
- Logged out
- Reason
- 自行鍵入
About this record
Access comprehensive regulatory information for Konya Rheumatoid Factor Reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3ca0e73d8176d4c2579afe35cc995375 and manufactured by KAMIYA BIOMEDICAL COMPANY. The authorized representative in Taiwan is TUNYEN ENTERPRISE CORPORATION.
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