Manufacturer

MagBio Genomics

United StatesLegal entities : MagBio Genomics, Inc.

Markets : Germany · United States

Approvals : EU – class A · United States (FDA) – 510(k) : 1 · class II · latest in 2022 · see on the FDA website

EU representative : CEpartner4U (Netherlands)

Website info@magbiogenomics.com

3 categories, 14 models including 14 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Category	EMDN code	Registered models	Class	Contact
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	HighPrep PCR - DX (1 mL) Device for post-PCR and post-enzymatic reaction clean-up HighPrep PCR - DX (100 mL) Device for post-PCR and post-enzymatic reaction clean-up HighPrep PCR - DX (1000 mL) Device for post-PCR and post-enzymatic reaction clean-up HighPrep PCR - DX (250 mL) Device for post-PCR and post-enzymatic reaction clean-up HighPrep PCR - DX (5 mL) Device for post-PCR and post-enzymatic reaction clean-up 2 others HighPrep PCR - DX (50 mL) Device for post-PCR and post-enzymatic reaction clean-up HighPrep PCR - DX (500 mL) Device for post-PCR and post-enzymatic reaction clean-up	A IVDR	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	HighPrep Viral DNA & RNA Kit - DX (20 preps) Kit for viral RNA and DNA isolation HighPrep Viral DNA & RNA Kit - DX (384 preps) Kit for viral RNA and DNA isolation HighPrep Viral DNA & RNA Kit - DX (3840 preps) Kit for viral RNA and DNA isolation HighPrep Viral DNA & RNA Kit - DX (96 preps) Kit for viral RNA and DNA isolation	A IVDR	EUDAMED record Report an error
Samples collection devices - other	W05019099	MagCTL Collection Tube (100 tubes) Device for isolation of nucleic acids from sample collection/lysis buffer MagCTL Collection Tube (2500 tubes) Device for isolation of nucleic acids from sample collection/lysis buffer MagCTL Collection Tube (5 tubes) Device for isolation of nucleic acids from sample collection/lysis buffer	A IVDR	EUDAMED record Report an error

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