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ILIA PM-SCL ANTIBODY DETECTION REAGENT - Taiwan Registration 07ac2736ab4511b6a9dc244195581224

Access comprehensive regulatory information for ILIA PM-SCL ANTIBODY 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 07ac2736ab4511b6a9dc244195581224 and manufactured by PHADIA AB;; PHADIA GMBH. The authorized representative in Taiwan is PHADIA TAIWAN INC..

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07ac2736ab4511b6a9dc244195581224
Registration Details
Taiwan FDA Registration: 07ac2736ab4511b6a9dc244195581224
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Device Details

ILIA PM-SCL ANTIBODY DETECTION REAGENT
TW: ๅฎœ็ซ‹ไบžPM-SclๆŠ—้ซ”ๆชขๆธฌ่ฉฆๅŠ‘
Risk Class 2

Registration Details

07ac2736ab4511b6a9dc244195581224

DHA00602472306

Company Information

Sweden;;Germany

Product Details

The ILIA PM-Scl antibody assay is used for the in vitro quantitative determination of IgG antibodies to PM-Scl in human serum and plasma. EliA PM-Scl was measured using the EliA IgG method on the Phadia 100 and Phadia 250 instruments. Performance changes (new applicable models) are: as detailed in the approved version of the Chinese manual.

C Immunology and microbiology

C.5100 ๆŠ—ๆ ธๆŠ—้ซ”ๅ…็–ซ่ฉฆ้ฉ—็ณป็ตฑ

import

Dates and Status

May 06, 2013

May 06, 2028