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COBAS AmpliPrep/COBAS TaqMan CMV Test - Taiwan Registration 8f6250a2207e2c895b5267573abbc45c

Access comprehensive regulatory information for COBAS AmpliPrep/COBAS TaqMan CMV Test in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8f6250a2207e2c895b5267573abbc45c and manufactured by ROCHE MOLECULAR SYSTEMS, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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8f6250a2207e2c895b5267573abbc45c
Registration Details
Taiwan FDA Registration: 8f6250a2207e2c895b5267573abbc45c
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Device Details

COBAS AmpliPrep/COBAS TaqMan CMV Test
TW: ็พ…ๆฐๅ…จ่‡ชๅ‹•้”ๅฏๅทจ็ดฐ่ƒž็—…ๆฏ’้‡ๆ ธ้…ธๆชข้ฉ—่ฉฆๅŠ‘
Risk Class 2
MD

Registration Details

8f6250a2207e2c895b5267573abbc45c

Ministry of Health Medical Device Import No. 026713

DHA05602671306

Company Information

United States

Product Details

This product needs to be used with COBAS AmpliPrep instrument for automatic sample extraction, and then use COBAS TaqMan Analyzer or COBAS TaqMan 48 Analyzer for nucleic acid amplification and detection to quantitatively detect CMV DNA in human EDTA plasma.

C Immunology and microbiology devices

C3175 CMV serum reagent

Imported from abroad

Dates and Status

Oct 08, 2014

Oct 08, 2024