Taiwan FDA registration 7595d538da284c0090c8086afb81c4cb

EliA Calprotectin 2 Calibrators

TW: 宜立亞鈣衛蛋白2校正試劑組
Taiwan flagTaiwan·Risk Class 2·MD·PHADIA AB·Registered Nov 01, 2017 – Nov 01, 2027Active
Registration details
Analysis ID
7595d538da284c0090c8086afb81c4cb
License Form
Ministry of Health Medical Device Import No. 030454
Customs Code
DHA05603045400
Company information
Manufacturer
PHADIA AB
Manufacturer Country
Sweden
Authorized Representative
PHADIA TAIWAN INC.
Product details
Intended Use
This product needs to be equipped with Fadia 250 instrument, and the Ilia Calprotectin 2 correction tablet needs to use the microwell slot of the EILIA Calprotectin 2 correction to establish the calprotectin 2 calibration curve using the Ilia Calprotectin 2 method to evaluate the patient's specimen. The quality of the Ifelia 2 calibration curve is required to use the microwell groove of the Ilivisatin 2 calibration to control the effectiveness of the calprotectin 2 correction curve on the Fadia 250 instrument. Performance changes: This product needs to be equipped with Fadia 200 and Fadia 250 instruments, and the EILIGAN Calprotectin 2 correction tablet needs to use the microwell slot of the EILIGAN Calprotectin 2 correction to establish the calprotectin 2 calibration curve using the EIFIA Calprotectin 2 method to evaluate the patient's specimen. The quality of the Electrin 2 calibration curve of Ilia Calprotectin 2 requires the use of microwell grooves for the calibration of Ilivimidin 2 to control the effectiveness of the Calprotectin 2 correction curve on the Fadia 200 and Fadia 250 instruments.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A1150 calibrate
Import Information
Imported from abroad
Dates and status
Registration Date
Nov 01, 2017
Expiry Date
Nov 01, 2027
About this record

Access comprehensive regulatory information for EliA Calprotectin 2 Calibrators in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7595d538da284c0090c8086afb81c4cb and manufactured by PHADIA AB. The authorized representative in Taiwan is PHADIA TAIWAN INC..

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