RIDA GENE 奈氏病毒 GI/GII
K 號：K171511 · 2017-08-21
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器材摘要
RIDA GENE Norovirus GI/GII is the device name listed in this FDA 510(k) record. The listed applicant is R-Biopharm AG. It received FDA 510(k) clearance on 2017-08-21 under 510(k) number K171511. The device is classified under product code PIQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the RIDA GENE Norovirus GI/GII?
RIDA GENE Norovirus GI/GII is a medical device that received FDA 510(k) clearance on 2017-08-21. The listed applicant is R-Biopharm AG. The 510(k) number is K171511.
When did RIDA GENE Norovirus GI/GII receive FDA 510(k) clearance?
RIDA GENE Norovirus GI/GII received FDA 510(k) clearance on 2017-08-21, under 510(k) number K171511.
Who is the listed applicant for RIDA GENE Norovirus GI/GII?
The FDA 510(k) record lists R-Biopharm AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RIDA GENE Norovirus GI/GII?
The FDA product code for RIDA GENE Norovirus GI/GII is PIQ.
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官方來源
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