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Espert hepatitis B virus detection kit - Taiwan Registration c11231057bf31635afa5a7f487650347

Access comprehensive regulatory information for Espert hepatitis B virus detection kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number c11231057bf31635afa5a7f487650347 and manufactured by CEPHEID AB. The authorized representative in Taiwan is PROGRESSIVE GROUP INC..

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c11231057bf31635afa5a7f487650347
Registration Details
Taiwan FDA Registration: c11231057bf31635afa5a7f487650347
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Device Details

Espert hepatitis B virus detection kit
TW: ่‰พๆ–ฏๆŸ็‰นBๅž‹่‚็‚Ž็—…ๆฏ’ๆชขๆธฌ่ฉฆๅŠ‘็ต„
Risk Class 3

Registration Details

c11231057bf31635afa5a7f487650347

DHA05603327907

Company Information

Sweden

Product Details

This product is an in vitro diagnostic reagent for polymerase chain chain reaction, which is used with the automatic GeneXpert Dx instrument system to quantitatively detect the content of hepatitis B virus (HBV) DNA in serum or plasma (EDTA) of patients with chronic hepatitis B infection.

B Hematology, pathology, and genetics

B.4020 Analysis of specific tests

import

Dates and Status

Feb 20, 2020

Feb 20, 2030