MGB Alert® HHV8 Probe Mix ASR - 48 Reactions M800598

GUDID 03661540950308

"MGB Alert® HHV8 Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the ORF26 gene region in HHV8. The mix consists of one probe at 0.72 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm."

ELITECH GROUP INC.

Human herpesvirus 8 (HHV8) nucleic acid IVD, kit, nucleic acid technique (NAT) Human herpesvirus 8 (HHV8) nucleic acid IVD, kit, nucleic acid technique (NAT) Human herpesvirus 8 (HHV8) nucleic acid IVD, kit, nucleic acid technique (NAT) Human herpesvirus 8 (HHV8) nucleic acid IVD, kit, nucleic acid technique (NAT) Human herpesvirus 8 (HHV8) nucleic acid IVD, kit, nucleic acid technique (NAT) Human herpesvirus 8 (HHV8) nucleic acid IVD, kit, nucleic acid technique (NAT) Human herpesvirus 8 (HHV8) nucleic acid IVD, kit, nucleic acid technique (NAT) Human herpesvirus 8 (HHV8) nucleic acid IVD, kit, nucleic acid technique (NAT) Human herpesvirus 8 (HHV8) nucleic acid IVD, kit, nucleic acid technique (NAT) Human herpesvirus 8 (HHV8) nucleic acid IVD, kit, nucleic acid technique (NAT) Human herpesvirus 8 (HHV8) nucleic acid IVD, kit, nucleic acid technique (NAT) Human herpesvirus 8 (HHV8) nucleic acid IVD, kit, nucleic acid technique (NAT) Human herpesvirus 8 (HHV8) nucleic acid IVD, kit, nucleic acid technique (NAT) Human herpesvirus 8 (HHV8) nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID03661540950308
NIH Device Record Keye47ebd46-a1ce-4e0d-854d-d4174b2d00c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameMGB Alert® HHV8 Probe Mix ASR - 48 Reactions
Version Model NumberM800598
Catalog NumberM800598
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
GS103661540950308 [Primary]
GS103661540950308 [Primary]
GS103661540950308 [Primary]
GS103661540950308 [Primary]
GS103661540950308 [Primary]
GS103661540950308 [Primary]
GS103661540950308 [Primary]
GS103661540950308 [Primary]
GS103661540950308 [Primary]
GS103661540950308 [Primary]
GS103661540950308 [Primary]
GS103661540950308 [Primary]
GS103661540950308 [Primary]
GS103661540950308 [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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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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