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Roche Cobanes automatic chlamydomia/gonococcal nucleic acid detection reagent - Taiwan Registration a07970fd53e199687d15a2a810463eb7

Access comprehensive regulatory information for Roche Cobanes automatic chlamydomia/gonococcal nucleic acid detection reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number a07970fd53e199687d15a2a810463eb7 and manufactured by Roche Molecular Systems, Inc.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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a07970fd53e199687d15a2a810463eb7
Registration Details
Taiwan FDA Registration: a07970fd53e199687d15a2a810463eb7
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Device Details

Roche Cobanes automatic chlamydomia/gonococcal nucleic acid detection reagent
TW: ็พ…ๆฐๅฏ้œธๆ–ฏๅ…จ่‡ชๅ‹•ๆŠซ่กฃ่Œ/ๆท‹่Œๆ ธ้…ธๆชขๆธฌ่ฉฆๅŠ‘
Risk Class 2

Registration Details

a07970fd53e199687d15a2a810463eb7

DHA05603436403

Company Information

United States

Product Details

ๆœฌ็”ขๅ“็‚บ้ซ”ๅค–่จบๆ–ท่ฉฆๅŠ‘,ๆญ้…cobas 6800/8800็ณป็ตฑ,ๅˆฉ็”จๅณๆ™‚่šๅˆ้…ถ้ˆๅๆ‡‰ๅฎšๆ€งๅตๆธฌๆชข้ซ”ไธญ็ ‚็œผๆŠซ่กฃ่Œ(Chlamydia trachomatis, CT)ๅŠ/ๆˆ–ๆท‹็—…้›™็ƒ่Œ(Neisseria gonorrhoeae, NG)ๆ ธ้…ธ่ฉฆ้ฉ—. ๆ–ฐๅขžๆ•ˆ่ƒฝ:ๆœฌ็”ขๅ“(09040501190)็‚บ้ซ”ๅค–่จบๆ–ท่ฉฆๅŠ‘,ๆญ้…cobas 5800/6800/8800็ณป็ตฑ,ๅˆฉ็”จๅณๆ™‚่šๅˆ้…ถ้ˆๅๆ‡‰ๅฎšๆ€งๆชขๆธฌ็ ‚็œผๆŠซ่กฃ่Œ(Chlamydia trachomatis, CT)ไปฅๅŠ/ๆˆ–ๆ˜ฏๆท‹็—…้›™็ƒ่Œ(Neisseria gonorrhoeae, NG)ๆ ธ้…ธ่ฉฆ้ฉ—.

C Immunology and microbiology

C.3390 ๅฅˆ็‘Ÿๆฐ่Œๅฑฌ็›ดๆŽฅ่ก€ๆธ…่ฉฆๅŠ‘;; C.3120 ๆŠซ่กฃ่Œ่ก€ๆธ…่ฉฆๅŠ‘

Input;; QMS/QSD

Dates and Status

Feb 25, 2021

Feb 25, 2026