QC Sets and Panels: Helix Elite™ 8246-SPL

GUDID 70845357044388

QC Sets and Panels: Helix Elite™ Flu/RSV/SARS-CoV-2 Control Panel Sample Kit

MICROBIOLOGICS INC.

Multiple-genus respiratory virus nucleic acid IVD, control
Primary Device ID70845357044388
NIH Device Record Keye3f80794-8796-4d7d-b5af-ff101803c42a
Commercial Distribution StatusIn Commercial Distribution
Brand NameQC Sets and Panels: Helix Elite™
Version Model Number8246-SPL
Catalog Number8246-SPL
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS170845357044388 [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 Date2024-03-26
Device Publish Date2024-03-18

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