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"Kaijie" Neumodis Epstein-Barr Virus Nucleic Acid Test Reagent Set Calibration Solution - Taiwan Registration dbef05ecdd10e4846fb40389c4087497

Access comprehensive regulatory information for "Kaijie" Neumodis Epstein-Barr Virus Nucleic Acid Test Reagent Set Calibration Solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number dbef05ecdd10e4846fb40389c4087497 and manufactured by NeuMoDx Molecular, Inc.. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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dbef05ecdd10e4846fb40389c4087497
Registration Details
Taiwan FDA Registration: dbef05ecdd10e4846fb40389c4087497
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Device Details

"Kaijie" Neumodis Epstein-Barr Virus Nucleic Acid Test Reagent Set Calibration Solution
TW: "ๅ‡ฑๆฐ" ็ด่Žซๅธๆ–ฏ EB ็—…ๆฏ’ๆ ธ้…ธๆชข้ฉ—่ฉฆๅŠ‘็ต„ๆ กๆญฃๆถฒ
Risk Class 2

Registration Details

dbef05ecdd10e4846fb40389c4087497

DHA05603705801

Company Information

United States

Product Details

ๆœฌ็”ขๅ“ๅฏๆญ้… NeuMoDx EBV Quant Assay 2.0 ไฝฟ็”จ,ไปฅ็ขบ็ซ‹่ˆ‡็‰นๅฎšๆ‰นๆฌก NeuMoDx EBV Quant Test Strip 2.0 ็›ธ้—œ็š„ๆ กๆญฃไฟ‚ๆ•ธ,ไธฆๅœจ NeuMoDx 288 Molecular System ๆˆ– NeuMoDx 96 Molecular System (NeuMoDx System(s)) ่ˆ‡ๆจ™ๆบ–ๆ›ฒ็ทšไธ€่ตทไฝฟ็”จ,ไปฅ้€ฒ่กŒๆบ–็ขบ็š„ๅฎš้‡้ซ”ๅค–่จบๆ–ทๆชขๆธฌ,้‡ๅŒ–ไบบ้กž่ก€ๆผฟๆจฃๅ“ไธญ็š„Epstein-Barr ็—…ๆฏ’ (EBV) DNA.

A Clinical chemistry and clinical toxicology

A.1150 Calibrated Products

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

Feb 01, 2024

Feb 01, 2029