Taiwan FDA registration f95436a351e7e4a3e17e4b6760f7d915
"Abbot" Enterovirus 71 immunoglobulin M antibody rapid test
TW: "亞培"百而靈腸病毒71型免疫球蛋白M抗體快速檢驗
Taiwan·Risk Class 2·ABBOTT DIAGNOSTICS KOREA INC.·Registered Mar 04, 2013 – Mar 04, 2028ActiveRegistration details
- Analysis ID
- f95436a351e7e4a3e17e4b6760f7d915
- Customs Code
- DHA00602454801
Company information
- Manufacturer
- ABBOTT DIAGNOSTICS KOREA INC.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- Abbott Rapid Diagnostics Health Corp.
Product details
- Intended Use
- Enterovirus type 71 IgM antibody was qualitatively detected in human serum or plasma samples by solid-phase immunochromography. This test only provides preliminary test results, and more specific diagnostic tools, such as virus isolation, PCR and RT-PCR, are needed to confirm enterovirus type 71 infection.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.0001 腸病毒71型血清試劑
- Import Information
- import
Dates and status
- Registration Date
- Mar 04, 2013
- Expiry Date
- Mar 04, 2028
About this record
Access comprehensive regulatory information for "Abbot" Enterovirus 71 immunoglobulin M antibody rapid test in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f95436a351e7e4a3e17e4b6760f7d915 and manufactured by ABBOTT DIAGNOSTICS KOREA INC.. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..
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