Taiwan FDA registration b0cdc17e4c4d16018ecaea9387cef7c8

Micro-Iron automatic microbial turbidimetry

TW: 微鐵克全自動微生物比濁儀

Taiwan·Risk Class 2·bioMérieux, Inc.·Registered Feb 26, 2020 – Feb 26, 2030Active

Registration details

Analysis ID: b0cdc17e4c4d16018ecaea9387cef7c8
Customs Code: DHA05603328107

Company information

Manufacturer: bioMérieux, Inc.
Manufacturer Country: United States
Authorized Representative: BIOMERIEUX CHINA LIMITED, TAIWAN BRANCH (HONG KONG)

Product details

Intended Use: This product can be used with the VITEK2 system to measure the optical density of microbial suspensions in proportion to microbial concentration, expressed in McFarland. This product is suitable for polystyrene tubing, reading from 0.00 to 4.00 McFarland, this product can be used as an in vitro diagnostic medical device.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.1645 Automatic Antibiotic Sensitivity Test System for Short Incubation Period
Import Information: import

Dates and status

Registration Date: Feb 26, 2020
Expiry Date: Feb 26, 2030

About this record

Access comprehensive regulatory information for Micro-Iron automatic microbial turbidimetry in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b0cdc17e4c4d16018ecaea9387cef7c8 and manufactured by bioMérieux, Inc.. The authorized representative in Taiwan is BIOMERIEUX CHINA LIMITED, TAIWAN BRANCH (HONG KONG).

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