MGB Alert® EBV Primer Mix ASR - 48 Reactions 800414

GUDID 03661540951480

"MGB Alert® EBV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from EBV (Epstein-Barr Virus). The mix consists of a total of 3.1 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 61 nucleic acid sequence from the p140 region of the BNRF1 gene of EBV."

ELITECH GROUP INC.

Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID03661540951480
NIH Device Record Keyee354eaa-2e88-47ea-a922-cb3a597acdf4
Commercial Distribution StatusIn Commercial Distribution
Brand NameMGB Alert® EBV Primer Mix ASR - 48 Reactions
Version Model Number800414
Catalog Number800414
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

Phone8994532725
EmailMDx@elitechgroup.com
Phone8994532725
EmailMDx@elitechgroup.com
Phone8994532725
EmailMDx@elitechgroup.com
Phone8994532725
EmailMDx@elitechgroup.com
Phone8994532725
EmailMDx@elitechgroup.com
Phone8994532725
EmailMDx@elitechgroup.com
Phone8994532725
EmailMDx@elitechgroup.com
Phone8994532725
EmailMDx@elitechgroup.com
Phone8994532725
EmailMDx@elitechgroup.com
Phone8994532725
EmailMDx@elitechgroup.com
Phone8994532725
EmailMDx@elitechgroup.com
Phone8994532725
EmailMDx@elitechgroup.com
Phone8994532725
EmailMDx@elitechgroup.com
Phone8994532725
EmailMDx@elitechgroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540951480 [Primary]
GS103661540951480 [Primary]
GS103661540951480 [Primary]
GS103661540951480 [Primary]
GS103661540951480 [Primary]
GS103661540951480 [Primary]
GS103661540951480 [Primary]
GS103661540951480 [Primary]
GS103661540951480 [Primary]
GS103661540951480 [Primary]
GS103661540951480 [Primary]
GS103661540951480 [Primary]
GS103661540951480 [Primary]
GS103661540951480 [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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