Helix Elite™ Molecular Standards: Inactivated Standard HE0026N

GUDID 10845357042009

Helix Elite™ Molecular Standards Inactivated Adenovirus 2 Strain Adenoid 6

MICROBIOLOGICS INC.

Adenovirus nucleic acid IVD, control

• Primary Device ID: 10845357042009
• NIH Device Record Key: de24e4bd-36fe-4e9b-a275-6fd0d20df1dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Helix Elite™ Molecular Standards: Inactivated Standard
• Version Model Number: HE0026N
• Catalog Number: HE0026N
• Company DUNS: 060467826
• Company Name: MICROBIOLOGICS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10845357042009 [Primary]

FDA Product Code

• OHQ: Multi-analyte controls unassayed

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-08
• Device Publish Date: 2020-04-30

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