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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PreciControl Anti-HBe
FDA UDI
Roche Diagnostics GmbH·04015630938872·Anti-HBe PC Elecsys
Elecsys Anti-HBe
FDA UDI
Roche Diagnostics GmbH·04015630940134·Anti-HBe Elecsys E2G 300
Elecsys Anti-HBe
FDA UDI
Roche Diagnostics GmbH·04015630938865·
LIAISON XL MUREX Anti-HBe
FDA UDI
DIASORIN SPA·08056771103428·
MINIMAL ACCESS ATTACHMENT
FDA Adverse Event
Malfunction
·HBE·Product code HBE·July 19, 2022
LIAISON XL MUREX Control Anti-HBe
FDA UDI
DIASORIN SPA·08056771103435·
ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Elos Accurate Hybrid Base H Engaging
FDA UDI
Elos Medtech Pinol A/S·05712821007803·The Elos Accurate Hybrid Base is a titanium bas...
Elos Accurate Hybrid Base Engaging
FDA UDI
Elos Medtech Pinol A/S·05712821011213·The Elos Accurate Hybrid Base is a titanium bas...
Elos Accurate Hybrid Base H Engaging
FDA UDI
Elos Medtech Pinol A/S·05712821006936·The Elos Accurate Hybrid Base is a titanium bas...
Elos Accurate Hybrid Base Engaging
FDA UDI
Elos Medtech Pinol A/S·05712821010476·The Elos Accurate Hybrid Base is a titanium bas...
Elos Accurate Hybrid Base H Engaging
FDA UDI
Elos Medtech Pinol A/S·05712821007988·The Elos Accurate Hybrid Base is a titanium bas...
Elos Accurate Hybrid Base H Engaging
FDA UDI
Elos Medtech Pinol A/S·05712821007001·The Elos Accurate Hybrid Base is a titanium bas...
Elos Accurate Hybrid Base H Engaging
FDA UDI
Elos Medtech Pinol A/S·05712821006974·The Elos Accurate Hybrid Base is a titanium bas...
Elos Accurate® Hybrid Base™ Engaging
FDA UDI
Elos Medtech Pinol A/S·05712821000347·The Elos Accurate Hybrid Base is a titanium bas...
Elos Accurate Hybrid Base H Engaging
FDA UDI
Elos Medtech Pinol A/S·05712821000316·The Elos Accurate Hybrid Base is a titanium bas...
Elos Accurate Hybrid Base H Engaging
FDA UDI
Elos Medtech Pinol A/S·05712821006950·The Elos Accurate Hybrid Base is a titanium bas...
Elos Accurate® Hybrid Base™ Engaging
FDA UDI
Elos Medtech Pinol A/S·05712821000392·The Elos Accurate Hybrid Base is a titanium bas...
Elos Accurate® Hybrid Base™ Engaging
FDA UDI
Elos Medtech Pinol A/S·05712821000361·The Elos Accurate Hybrid Base is a titanium bas...
Elos Accurate Hybrid Base H Engaging
FDA UDI
Elos Medtech Pinol A/S·05712821010445·The Elos Accurate Hybrid Base is a titanium bas...