Taiwan FDA registration 47c9c099c14b31d14c8622d8488a0671
IMMULITE 2000 Anti-CCP IgG
TW: 免疫特二千抗環瓜氨酸免疫球蛋白G檢驗試劑組
Taiwan·Risk Class 2·MD·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED·Registered Dec 10, 2013 – Dec 10, 2028ActiveRegistration details
- Analysis ID
- 47c9c099c14b31d14c8622d8488a0671
- License Form
- Ministry of Health Medical Device Import No. 025699
- Customs Code
- DHA05602569907
Company information
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED
- Manufacturer Country
- United Kingdom
- Authorized Representative
- SIEMENS HEALTHCARE LIMITED
Product details
- Intended Use
- This product is used with the IMMULITE 2000 analyzer to semi-quantitatively detect the specific IgG of anti-cyclic citrullinated (CCP) in human serum (including serum separation tubes) or plasma (EDTA or heparin lithium).
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C5775 Rheumatoid factor immunoassay system
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Dec 10, 2013
- Expiry Date
- Dec 10, 2028
About this record
Access comprehensive regulatory information for IMMULITE 2000 Anti-CCP IgG in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 47c9c099c14b31d14c8622d8488a0671 and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.
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