Taiwan FDA registration ae58690678d0e5f3742bfbd550362781

"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)

Taiwan·Risk Class 1·MD·MIACOM DIAGNOSTICS GMBH·Registered Mar 22, 2016 – Mar 22, 2021Expired

Registration details

Analysis ID: ae58690678d0e5f3742bfbd550362781
License Form: Ministry of Health Medical Device Import No. 016300
Customs Code: DHA09401630008

Company information

Manufacturer: MIACOM DIAGNOSTICS GMBH
Manufacturer Country: Germany
Authorized Representative: ARSENALS IVD CO., LTD.

Product details

Intended Use: 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.
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C9999 Other
Import Information: Imported from abroad

Dates and status

Registration Date: Mar 22, 2016
Expiry Date: Mar 22, 2021

About this record

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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