Helix Elite Molecular Standards

GUDID 80845357044422

MICROBIOLOGICS INC.

Multiple-type gastrointestinal pathogen nucleic acid IVD, control

• Primary Device ID: 80845357044422
• NIH Device Record Key: df55783a-7daf-4c48-957a-f779c1298be5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Helix Elite Molecular Standards
• Version Model Number: GS-0001
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	80845357044422 [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: 2025-08-22
• Device Publish Date: 2025-08-14

Devices Manufactured by MICROBIOLOGICS INC.

• 70845357044340 - QC Sets and Panels: Helix Elite™: 2025-09-16
• 70845357044395 - QC Sets and Panels: Helix Elite™: 2025-09-16
• 80845357044422 - Helix Elite Molecular Standards: 2025-08-22
• 80845357044422 - Helix Elite Molecular Standards: 2025-08-22
• 10845357044324 - Helix Elite™ Molecular Standards: Inactivated Standard: 2024-09-12 Helix Elite™ Molecular Standards Inactivated Negative Blank Control
• 70845357044364 - QC Sets and Panels: Helix Elite™: 2024-09-12 QC Sets and Panels: Helix Elite™ Rapid SARS-CoV-2 Control Panel
• 70845357044388 - QC Sets and Panels: Helix Elite™: 2024-03-26 QC Sets and Panels: Helix Elite™ Flu/RSV/SARS-CoV-2 Control Panel Sample Kit
• 10634853000138 - Fungal Serology: 2022-10-04 Immunodiffusion Agar Plates, 1 - 7 Well Pattern
• 10634853000145 - Fungal Serology: 2022-10-04 Immunodiffusion Agar Plates, 3 - 7 Well Pattern