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QUANTA Flash PR3 Calibrators - Taiwan Registration bb7c8c0e86a1c21b5eb051ebdf149308

Access comprehensive regulatory information for QUANTA Flash PR3 Calibrators in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number bb7c8c0e86a1c21b5eb051ebdf149308 and manufactured by INOVA DIAGNOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..

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bb7c8c0e86a1c21b5eb051ebdf149308
Registration Details
Taiwan FDA Registration: bb7c8c0e86a1c21b5eb051ebdf149308
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Device Details

QUANTA Flash PR3 Calibrators
TW: ๅ› ่ซพ็“ฆPR3ๅŒ–ๅญธๅ†ทๅ…‰ๅ…็–ซๅˆ†ๆžๆณ•ๆ กๆญฃๆถฒ
Risk Class 2
MD

Registration Details

bb7c8c0e86a1c21b5eb051ebdf149308

Ministry of Health Medical Device Import No. 027332

DHA05602733202

Company Information

United States

Product Details

This product is used in the BIO-FLASH instrument to establish a reference point for the working curve when semi-quantitatively measuring PR3 IgG antibodies in human serological samples by QUANTA Flash PR3 chemical cold light immunoassay.

A Clinical chemistry and clinical toxicology

A1150 calibrate

Imported from abroad

Dates and Status

May 07, 2015

May 07, 2025