MGB Alert® Enterovirus Primer Mix ASR - 48 Reactions 800336

GUDID 03661540951312

"MGB Alert® Enterovirus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Enterovirus. The mix consists of a total of 1.4 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 54 nucleic acid sequence from the 5’-UTR region of Enterovirus."

ELITECH GROUP INC.

Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT) Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT) Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT) Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT) Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT) Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT) Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT) Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT) Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT) Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT) Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT) Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT) Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT) Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT)
Primary Device ID03661540951312
NIH Device Record Key5e5c72f0-2780-43de-b70e-5e8a8288769a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMGB Alert® Enterovirus Primer Mix ASR - 48 Reactions
Version Model Number800336
Catalog Number800336
Company DUNS079696864
Company NameELITECH GROUP INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8004532725
EmailMDx@elitechgroup.com
Phone8004532725
EmailMDx@elitechgroup.com
Phone8004532725
EmailMDx@elitechgroup.com
Phone8004532725
EmailMDx@elitechgroup.com
Phone8004532725
EmailMDx@elitechgroup.com
Phone8004532725
EmailMDx@elitechgroup.com
Phone8004532725
EmailMDx@elitechgroup.com
Phone8004532725
EmailMDx@elitechgroup.com
Phone8004532725
EmailMDx@elitechgroup.com
Phone8004532725
EmailMDx@elitechgroup.com
Phone8004532725
EmailMDx@elitechgroup.com
Phone8004532725
EmailMDx@elitechgroup.com
Phone8004532725
EmailMDx@elitechgroup.com
Phone8004532725
EmailMDx@elitechgroup.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540951312 [Primary]
GS103661540951312 [Primary]
GS103661540951312 [Primary]
GS103661540951312 [Primary]
GS103661540951312 [Primary]
GS103661540951312 [Primary]
GS103661540951312 [Primary]
GS103661540951312 [Primary]
GS103661540951312 [Primary]
GS103661540951312 [Primary]
GS103661540951312 [Primary]
GS103661540951312 [Primary]
GS103661540951312 [Primary]
GS103661540951312 [Primary]

FDA Product Code

MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-16
Device Publish Date2020-09-08

Devices Manufactured by ELITECH GROUP INC.

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03661540951183 - MGB Alert® Parvovirus Probe Mix ASR - 48 Reactions2020-09-17 "MGB Alert® Parvovirus B19 Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide desi
03661540951190 - MGB Alert® Legionella Pneumophila Primer Mix ASR - 48 Reactions2020-09-17 MGB Alert® Legionella pneumophila Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic a
03661540951206 - MGB Alert® Legionella Pneumophila Probe Mix ASR - 48 Reactions2020-09-17 "MGB Alert® Legionella pneumophila Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleot
03661540951213 - MGB Alert® Pan Legionella Primer Mix ASR - 48 Reactions2020-09-17 "MGB Alert® Pan Legionella Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid seq
03661540951220 - MGB Alert® Pan Legionella Probe Mix ASR - 48 Reactions 2020-09-17 "MGB Alert® Pan Legionella Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide desi
03661540950018 - Zika ELITe MGB® - EUA2020-09-16 The United States (US) Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to authorize the use o

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