MagBio Genomics, Inc. MXCT-100

GUDID 00850045030018

Collect sample, lyse to extract RNA/DNA

Magbio Genomics, Inc.

Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00850045030018
NIH Device Record Key99ced519-4a3c-4b29-aa36-2b47cede3a40
Commercial Distribution StatusIn Commercial Distribution
Brand NameMagBio Genomics, Inc.
Version Model NumberMagXtract Collection Tube
Catalog NumberMXCT-100
Company DUNS078654815
Company NameMagbio Genomics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com
Phone(301) 302-0144
Emailsupport@magbiogenomics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850045030001 [Primary]
GS100850045030018 [Package]
Contains: 00850045030001
Package: [100 Units]
In Commercial Distribution

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-21
Device Publish Date2022-09-13

On-Brand Devices [MagBio Genomics, Inc. ]

00850045030841Isolation of nucleic acids from bacteria and human skin cells
00850045030834Isolation of nucleic acids from bacteria and human skin cells
00850045030827Isolation of nucleic acids from bacteria and human skin cells
00850045030810Isolation of nucleic acids from bacteria and human skin cells
00850045030544RNA and ss cDNA clean-up or concentration
00850045030537RNA and ss cDNA clean-up or concentration
00850045030520RNA and ss cDNA clean-up or concentration
00850045030513RNA and ss cDNA clean-up or concentration
00850045030506Sanger sequencing reaction clean-up / dye terminator removal
00850045030490Sanger sequencing reaction clean-up / dye terminator removal
00850045030483Sanger sequencing reaction clean-up / dye terminator removal
00850045030476Sanger sequencing reaction clean-up / dye terminator removal
00850045030469DNA quantitation and normalization of DNA concentration
00850045030452DNA quantitation and normalization of DNA concentration
00850045030445DNA quantitation and normalization of DNA concentration
00850045030391Viral/Pathogen RNA and DNA isolation
00850045030384Viral/Pathogen RNA and DNA isolation
00850045030377Viral/Bacterial RNA and DNA isolation
00850045030360Viral/Bacterial RNA and DNA isolation
00850045030353Viral RNA isolation - KingFisher MVP II Alternative
00850045030346Viral RNA isolation
00850045030339cfDNA (ccfDNA) extraction
00850045030322cfDNA (ccfDNA) extraction
00850045030315cfDNA (ccfDNA) extraction
00850045030308cfDNA (ccfDNA) stabilization and extraction
00850045030292cfDNA (ccfDNA) stabilization and extraction
00850045030285cfDNA (ccfDNA) stabilization and extraction
00850045030278Genomic DNA isolation from 30 mg lysate of tissues or cultured cells
00850045030261Genomic DNA isolation from 30 mg lysate of tissues or cultured cells
00850045030254RNA isolation from tissues, cultured cells, and whole blood
00850045030247RNA isolation from tissues, cultured cells, and whole blood
00850045030230RNA isolation from tissues, cultured cells, and whole blood
00850045030193Plasmid DNA isolation
00850045030186Plasmid DNA isolation
00850045030179Plasmid DNA isolation
00850045030162Viral RNA and DNA isolation
00850045030155Post-PCR and post-enzymatic reaction clean-up
00850045030148Post-PCR and post-enzymatic reaction clean-up
00850045030131Post-PCR and post-enzymatic reaction clean-up
00850045030124Post-PCR and post-enzymatic reaction clean-up
00850045030117Genomic DNA isolation from FFPE tissues
00850045030100Genomic DNA isolation from FFPE tissues
00850045030094Blood and tissue gDNA extraction
00850045030087Blood and tissue gDNA extraction
00850045030070Viral RNA and DNA isolation
00850045030063Viral RNA and DNA isolation
00850045030056Collection of pathogen sample, lysis, and transportation while ensuring stability of DNA and RNA
00850045030049Collection of pathogen sample, lysis, and transportation while ensuring stability of DNA and RNA
00850045030032Collection of pathogen sample, lysis, and transportation while ensuring stability of DNA and RNA
00850045030025Collection of pathogen sample, lysis, and transportation while ensuring stability of DNA and RNA

Trademark Results [MagBio Genomics, Inc.]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MAGBIO GENOMICS, INC.
MAGBIO GENOMICS, INC.
87917151 5659841 Live/Registered
Magbio Genomics Inc
2018-05-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.