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"Miacom" hemoFISH Gram Negative Panel (Non-sterile) - Taiwan Registration ae58690678d0e5f3742bfbd550362781

Access comprehensive regulatory information for "Miacom" hemoFISH Gram Negative Panel (Non-sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number ae58690678d0e5f3742bfbd550362781 and manufactured by MIACOM DIAGNOSTICS GMBH. The authorized representative in Taiwan is ARSENALS IVD CO., LTD..

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ae58690678d0e5f3742bfbd550362781
Registration Details
Taiwan FDA Registration: ae58690678d0e5f3742bfbd550362781
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Device Details

"Miacom" hemoFISH Gram Negative Panel (Non-sterile)
TW: "麥康" 螢光原位雜交探針革蘭氏陰性試劑組 (未滅菌)
Risk Class 1
MD

Registration Details

ae58690678d0e5f3742bfbd550362781

Ministry of Health Medical Device Import No. 016300

DHA09401630008

Company Information

Germany

Product Details

本產品為核酸雜交試劑,用於鑑定血液培養檢體中的多種細菌感染,以作為輔助診斷之依據,鑑定菌種包含Eubacteria (Positive control)、Enterobacteriaceae、Escherichia coli、Klebsiella pneumoniae、Serratia spp.、Proteus mirabilis、Proteus vulgaris、Salmonella spp.、Pseudomonas aeruginosa、Acinetobacter spp.、Stenotrophomonas maltophilia、Haemophilus influenzae.

C Immunology and microbiology devices

C9999 Other

Imported from abroad

Dates and Status

Mar 22, 2016

Mar 22, 2021