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NOVA Lite DAPI ANCA Kit - Taiwan Registration 4b28a5ba150382aad5a18c8d18c8890a

Access comprehensive regulatory information for NOVA Lite DAPI ANCA Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4b28a5ba150382aad5a18c8d18c8890a and manufactured by INOVA Diagnostics, Inc. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..

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4b28a5ba150382aad5a18c8d18c8890a
Registration Details
Taiwan FDA Registration: 4b28a5ba150382aad5a18c8d18c8890a
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Device Details

NOVA Lite DAPI ANCA Kit
TW: ๅ› ่ซพ็“ฆๆŠ—ๅ—œไธญๆ€ง็™ฝ่ก€็ƒ็ดฐ่ƒž่ณชๆŠ—้ซ”ๆชขๆธฌ่ฉฆๅŠ‘
Risk Class 2
MD

Registration Details

4b28a5ba150382aad5a18c8d18c8890a

Ministry of Health Medical Device Import No. 032479

DHA05603247900

Company Information

United States

Product Details

This product uses indirect immunofluorescent assay (IFA) to qualitatively and semi-quantitatively detect human serum anti-neutrophil cytoplasmic antibodies (ANCA).

C Immunology and microbiology devices

C5660 Multiple autologous antibody immunoassay system

Imported from abroad

Dates and Status

Aug 12, 2019

Aug 12, 2024