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MagBio Genomics, Inc.

United States·US-MF-000038221

Last updated May 26, 2026

Information

Country: United States
Address: 200, Professional Drive, Gaithersburg, United States
Website: www.magbiogenomics.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 301 302 01 44
PRRC Contact: Delcie Kestner
EUDAMED SRN: US-MF-000038221
FDA FEI Number: —
DUNS Number: 078654815

Catalogue (57)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
MagBio Genomics, Inc.	HighPrep™ Viral RNA Kit KingFisher™ Format	FDA UDI	N/A	Active
MagBio Genomics, Inc.	cfKapture™ 21 Kit	FDA UDI	N/A	Active
MagBio Genomics, Inc.	HighPrep Tissue DNA/RNA Co-Isolation Kit	FDA UDI	N/A	Active
MagBio Genomics, Inc.	HighPrep™ Viral/Bacterial DNA/RNA Kit	FDA UDI	N/A	Active
MagBio Genomics, Inc.	HighPrep™ Viral/Pathogen DNA/RNA	FDA UDI	N/A	Active
MagBio Genomics, Inc.	QuickPrep Cell DNA/RNA Nucleic Acid Purification Kit	FDA UDI	N/A	Active
MagBio Genomics, Inc.	HighPrep™ RNA Elite Clean-up System	FDA UDI	N/A	Active
MagBio Genomics, Inc.	HighPrep™ DTR Clean-up System	FDA UDI	N/A	Active
MagBio Genomics, Inc.	HighPrep Total RNA Plus	FDA UDI	N/A	Active
MagBio Genomics, Inc.	HighPrep™ Blood & Tissue DNA	FDA UDI	N/A	Active
MagBio Genomics, Inc.	HighPrep™ DTR Clean-up System	FDA UDI	N/A	Active
MagBio Genomics, Inc.	QuickPrep Cell DNA/RNA Nucleic Acid Purification Kit	FDA UDI	N/A	Active
MagBio Genomics, Inc.	cfKapture™ Kit	FDA UDI	N/A	Active
MagBio Genomics, Inc.	MagQuant™ Plus DNA V2	FDA UDI	N/A	Active
MagBio Genomics, Inc.	MagQuant™ Plus DNA V2	FDA UDI	N/A	Active
MagBio Genomics, Inc.	cfKapture™ Kit	FDA UDI	N/A	Active
MagBio Genomics, Inc.	QuickPrep Cell DNA/RNA Nucleic Acid Purification Kit	FDA UDI	N/A	Active
MagBio Genomics, Inc.	HighPrep™ Viral/Bacterial DNA/RNA Kit	FDA UDI	N/A	Active
MagBio Genomics, Inc.	HighPrep™ FFPE DNA	FDA UDI	N/A	Active
MagBio Genomics, Inc.	HighPrep™ Viral DNA/RNA	FDA UDI	N/A	Active
MagBio Genomics, Inc.	HighPrep™ Plasmid DNA Plus	FDA UDI	N/A	Active
MagBio Genomics, Inc.	HighPrep Tissue DNA/RNA Co-Isolation Kit	FDA UDI	N/A	Active
MagBio Genomics, Inc.	HighPrep™ RNA Elite Clean-up System	FDA UDI	N/A	Active
MagBio Genomics, Inc.	HighPrep Total RNA Plus	FDA UDI	N/A	Active
MagBio Genomics, Inc.	cfKapture™ 21 Kit	FDA UDI	N/A	Active
MagBio Genomics, Inc.	HighPrep™ RNA Elite Clean-up System	FDA UDI	N/A	Active
MagBio Genomics, Inc.	HighPrep™ RNA Elite Clean-up System	FDA UDI	N/A	Active
MagBio Genomics, Inc.	cfKapture™ 21 Kit	FDA UDI	N/A	Active
MagBio Genomics, Inc.	HighPrep™ FFPE DNA	FDA UDI	N/A	Active
MagBio Genomics, Inc.	MagQuant™ Plus DNA V2	FDA UDI	N/A	Active
MagBio Genomics, Inc.	HighPrep™ DTR Clean-up System	FDA UDI	N/A	Active
MagBio Genomics, Inc.	HighPrep™ Blood & Tissue DNA	FDA UDI	N/A	Active
MagBio Genomics, Inc.	QuickPrep Cell DNA/RNA Nucleic Acid Purification Kit	FDA UDI	N/A	Active
MagBio Genomics, Inc.	cfKapture™ Kit	FDA UDI	N/A	Active
MagBio Genomics, Inc.	HighPrep™ Plasmid DNA Plus	FDA UDI	N/A	Active
MagBio Genomics, Inc.	HighPrep™ Plasmid DNA Plus	FDA UDI	N/A	Active
MagBio Genomics, Inc.	HighPrep™ DTR Clean-up System	FDA UDI	N/A	Active
MagBio Genomics, Inc.	HighPrep™ Viral/Pathogen DNA/RNA	FDA UDI	N/A	Active
MagBio Genomics, Inc.	MagBio CTL Medium VIRAL (1000 mL)	FDA UDI	Class I	Active
MagBio Genomics, Inc.	MagBio CTL Medium MAX (500 mL)	FDA UDI	Class I	Active
MagBio Genomics, Inc.	MagBio CTL Medium MAX (1000 mL)	FDA UDI	Class I	Active
MagBio Genomics, Inc.	HighPrep Total RNA Plus	FDA UDI	N/A	Active
HighPrep PCR - DX (100 mL)	AC-60100E	EUDAMEDFDA UDI	Class A	Active
HighPrep PCR - DX (1 mL)	AC-60001E	EUDAMED	Class A	Active
HighPrep PCR - DX (500 mL)	AC-60500E	EUDAMEDFDA UDI	Class A	Active
HighPrep Viral DNA & RNA Kit - DX (384 preps)	HPV-DR96x4E	EUDAMEDFDA UDI	Class A	Active
MagXtract Collection Tube	K212113	FDA 510(k)	Class II	Active
HighPrep Viral DNA & RNA Kit - DX (20 preps)	HPV-DR20E	EUDAMEDFDA UDI	Class A	Active
MagCTL Collection Tube (2500 tubes)	MXCT-2500	EUDAMED	Class A	Active
HighPrep PCR - DX (50 mL)	AC-60050E	EUDAMEDFDA UDI	Class A	Active

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