Taiwan FDA registration 000a05afa39d90dc0633a40f44cf3023
Wetex immunodiagnostic products CMV immunoglobulin M reagent group
TW: 維特司免疫診斷產品巨細胞病毒免疫球蛋白M試劑組
Taiwan·Risk Class 2·ORTHO-CLINICAL DIAGNOSTICS·Registered Feb 05, 2009 – Feb 05, 2029ActiveRegistration details
- Analysis ID
- 000a05afa39d90dc0633a40f44cf3023
- Customs Code
- DHA00601994007
Company information
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
- Manufacturer Country
- United Kingdom
- Authorized Representative
- DKSH TAIWAN LTD.
Product details
- Intended Use
- In vitro qualitative testing for the presence of cytomegalovirus (CMV) IgM antibodies in human serum and plasma (heparin, EDTA, or sodium citrate anticoagulation) samples.
- Product Type (Level 1)
- A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
- Product Type (Level 2)
- C.3175 巨細胞病毒血清試劑;; A.1150 校正品
- Import Information
- import
Dates and status
- Registration Date
- Feb 05, 2009
- Expiry Date
- Feb 05, 2029
About this record
Access comprehensive regulatory information for Wetex immunodiagnostic products CMV immunoglobulin M reagent group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 000a05afa39d90dc0633a40f44cf3023 and manufactured by ORTHO-CLINICAL DIAGNOSTICS. The authorized representative in Taiwan is DKSH TAIWAN LTD..
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