Helix Elite™ Molecular Standards: Synthetic Standard HE0014S

GUDID 10845357041866

Helix Elite™ Molecular Standards West Nile Virus Synthetic RNA

MICROBIOLOGICS INC.

Multiple tropical pathogen nucleic acid IVD, control
Primary Device ID10845357041866
NIH Device Record Key962ac1b6-8f87-43be-9c51-d9e6e1fe4c0d
Commercial Distribution StatusIn Commercial Distribution
Brand NameHelix Elite™ Molecular Standards: Synthetic Standard
Version Model NumberHE0014S
Catalog NumberHE0014S
Company DUNS060467826
Company NameMICROBIOLOGICS INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com
Phone+1(320)253-7400
Emailtechsupport@microbiologics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110845357041866 [Primary]

FDA Product Code

OHQMulti-analyte controls unassayed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-08
Device Publish Date2020-04-30

On-Brand Devices [Helix Elite™ Molecular Standards: Synthetic Standard]

10845357041996Helix Elite™ Molecular Standards Human papillomavirus 18 Synthetic DNA
10845357041989Helix Elite™ Molecular Standards Treponema pallidum Synthetic DNA
10845357041972Helix Elite™ Molecular Standards Human papillomavirus 16 Synthetic DNA
10845357041965Helix Elite™ Molecular Standards Cyclospora cayetanensis Synthetic DNA
10845357041880Helix Elite™ Molecular Standards Eastern Equine Encephalitis Virus Synthetic RNA
10845357041873Helix Elite™ Molecular Standards Dientamoeba fragilis Synthetic DNA
10845357041866Helix Elite™ Molecular Standards West Nile Virus Synthetic RNA
10845357041859Helix Elite™ Molecular Standards Norovirus GI.1 Synthetic RNA
10845357041842Helix Elite™ Molecular Standards Norovirus GII.4 Synthetic RNA
10845357041835Helix Elite™ Molecular Standards Plasmodium malariae Synthetic DNA
10845357041828Helix Elite™ Molecular Standards Plasmodium ovale Synthetic DNA
10845357041811Helix Elite™ Molecular Standards Plasmodium vivax Synthetic DNA
10845357041804Helix Elite™ Molecular Standards Plasmodium falciparum Synthetic DNA
10845357041798Helix Elite™ Molecular Standards Entamoeba dispar Synthetic DNA
10845357041781Helix Elite™ Molecular Standards Entamoeba histolytica Synthetic DNA
10845357041774Helix Elite™ Molecular Standards Giardia lamblia Synthetic DNA
10845357041767Helix Elite™ Molecular Standards Encephalitozoon intestinalis Synthetic DNA
10845357041750Helix Elite™ Molecular Standards Enterocytozoon bieneusi Synthetic DNA
10845357041743Helix Elite™ Molecular Standards Cryptosporidium parvum Synthetic DNA
10845357041736Helix Elite™ Molecular Standards Cryptosporidium hominis Synthetic DNA
10845357043631Helix Elite™ Molecular Standards SARS-CoV-2 Process Control (Pellet)
10845357043556Helix Elite™ Molecular Standards SARS-CoV-2 Process Control (Swab)

Trademark Results [Helix Elite]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HELIX ELITE
HELIX ELITE
86199844 5082578 Live/Registered
Microbiologics, Inc.
2014-02-21

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