Manufacturer

Zymo Research

United StatesLegal entities : Zymo Research Corp.

Markets : France · United States

Approvals : EU – class A · United States (FDA) – 510(k) : 2 · class II · latest in 2023 · see on the FDA website

EU representative : DAVID Catherine Elisabeth Marie (France)

4 categories, 11 models including 9 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	EZ DNA Methylation-Lightning Kit (200 rxns) D5030-E3 refs Quick-DNA-RNA™ HT - Dx (1000 preps) R2140-E3 refs ZymoBIOMICS 96 MagBead DNA Kit (Lysis Rack) D4302-E3 refs EZ-96 DNA Methylation-Lightning Kit (Deep-Well) - 2 x 96 Rxns D5033-E (no longer marketed) EZ-96 DNA Methylation-Lightning Kit (Shallow-Well) -2 x 96 Rxns D5032-E (no longer marketed)	A IVDR	EUDAMED record Report an error
Samples collection devices - other	W05019099	DNA/RNA Shield Collection Tube R1102-E3 refs DNA/RNA Shield Collection Tube w/ Swab - DX (2 ml fill)2 refs DNA/RNA Shield SafeCollect Swab Collection Kit (1mL) R1160-H2 refs	A IVDR	EUDAMED record Report an error
Saliva collection devices	W05019002	DNA/RNA Sample Collection Kit R2000-A DNA/RNA Shield SafeCollect Saliva Collection Kit R1160-E3 refs	A IVDR	EUDAMED record Report an error
Faeces collection devices	W05019001	DNA/RNA Shield Fecal Collection Tube (with Beads) - DX (1 tube/pk) R1101-E3 refs	A IVDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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