Helix Elite™ Molecular Standards: Synthetic Standard HE0046S

GUDID 10845357041972

Helix Elite™ Molecular Standards Human papillomavirus 16 Synthetic DNA

MICROBIOLOGICS INC.

Human papillomavirus (HPV) nucleic acid IVD, control

• Primary Device ID: 10845357041972
• NIH Device Record Key: 31f831b3-3f58-48c2-9976-57254ffee955
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Helix Elite™ Molecular Standards: Synthetic Standard
• Version Model Number: HE0046S
• Catalog Number: HE0046S
• 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: true
• 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
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10845357041972 [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

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

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