Helix Elite™ Molecular Standards: Inactivated Standard HE0057N

GUDID 10845357043266

Helix Elite™ Molecular Standards Human Papillomavirus 18 (HPV 18) Cellularity Control (Inactivated Pellet)

MICROBIOLOGICS INC.

Human papillomavirus (HPV) nucleic acid IVD, control

• Primary Device ID: 10845357043266
• NIH Device Record Key: 9fe9dded-84e7-4d54-8978-411effaa596a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Helix Elite™ Molecular Standards: Inactivated Standard
• Version Model Number: HE0057N
• Catalog Number: HE0057N
• 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	10845357043266 [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: Inactivated Standard]

• 10845357043273: Helix Elite™ Molecular Standards Negative Cellularity Control (Inactivated Pellet)
• 10845357043266: Helix Elite™ Molecular Standards Human Papillomavirus 18 (HPV 18) Cellularity Control (Inactiv
• 10845357043259: Helix Elite™ Molecular Standards Human Papillomavirus 16 (HPV 16) Cellularity Control (Inactiv
• 10845357042795: Helix Elite™ Molecular Standards Methicillin-Susceptible Staphylococcus epidermidis (MSSE) Ina
• 10845357042788: Helix Elite™ Molecular Standards Methicillin-Susceptible Staphylococcus aureus (MSSA) Inactiva
• 10845357042771: Helix Elite™ Molecular Standards Methicillin-Resistant Staphylococcus aureus (MRSA) Inactivate
• 10845357042672: Helix Elite™ Molecular Standards Inactivated Borrelia burgdorferi
• 10845357042214: Helix Elite™ Molecular Standards Inactivated Enterovirus D68
• 10845357042207: Helix Elite™ Molecular Standards Inactivated Cryptosporidium and Giardia
• 10845357042191: Helix Elite™ Molecular Standards Inactivated Chlamydia trachomatis/ Neisseria gonorrhoeae (CT/
• 10845357042184: Helix Elite™ Molecular Standards Inactivated Influenza A/B and Respiratory Syncytial Virus
• 10845357042177: Helix Elite™ Molecular Standards Inactivated Influenza A (H3N2) Virus
• 10845357042160: Helix Elite™ Molecular Standards Inactivated Trichomonas vaginalis Strain GL0028
• 10845357042153: Helix Elite™ Molecular Standards Inactivated Neisseria gonorrhoeae Strain GL0071
• 10845357042146: Helix Elite™ Molecular Standards Inactivated Cytomegalovirus High Control Strain AD-169
• 10845357042139: Helix Elite™ Molecular Standards Inactivated Cytomegalovirus Low Control Strain AD-169
• 10845357042122: Helix Elite™ Molecular Standards Inactivated Varicella Zoster Virus Strain VZ-10
• 10845357042115: Helix Elite™ Molecular Standards Inactivated Herpes Simplex Virus 2 Strain MS
• 10845357042108: Helix Elite™ Molecular Standards Inactivated Herpes Simplex Virus 1 Strain MacIntyre
• 10845357042092: Helix Elite™ Molecular Standards Inactivated Chlamydia trachomatis Strain LGV-2-434
• 10845357042085: Helix Elite™ Molecular Standards Inactivated Chlamydia pneumoniae CWL-029
• 10845357042078: Helix Elite™ Molecular Standards Inactivated Parainfluenza Virus 3 Strain C243
• 10845357042061: Helix Elite™ Molecular Standards Inactivated Parainfluenza Virus 2 Strain Greer
• 10845357042054: Helix Elite™ Molecular Standards Inactivated Parainfluenza Virus 1 Strain VP1
• 10845357042047: Helix Elite™ Molecular Standards Inactivated Influenza B Virus Strain Hong Kong/5/72
• 10845357042030: Helix Elite™ Molecular Standards Inactivated Influenza A (H1N1) Virus
• 10845357042023: Helix Elite™ Molecular Standards Inactivated Respiratory Syncytial Virus A Strain Long
• 10845357042016: Helix Elite™ Molecular Standards Inactivated Rotavirus Strain Simian SA-11
• 10845357042009: Helix Elite™ Molecular Standards Inactivated Adenovirus 2 Strain Adenoid 6
• 10845357043624: Helix Elite™ Molecular Standards Negative Cellularity Control (Inactivated Pellet)
• 10845357043594: Helix Elite™ Molecular Standards Negative Cellularity Control (Inactivated Swab)
• 10845357043570: Helix Elite™ Molecular Standards Inactivated SARS-CoV-2 Whole Virus (Swab)
• 10845357043563: Helix Elite™ Molecular Standards Inactivated SARS-CoV-2 Whole Virus (Pellet)
• 10845357044003: Helix Elite™ Molecular Standards Inactivated Macrolide-Resistant Mycoplasma Genitalium
• 10845357043990: Helix Elite™ Molecular Standards Inactivated Macrolide and Quinolone-Resistant Mycoplasma Geni
• 10845357043952: Helix Elite™ Molecular Standards Inactivated SARS-CoV-2 B.1.351 Whole Virus (Swab)
• 10845357043945: Helix Elite™ Molecular Standards Inactivated SARS-CoV-2 B.1.351 Whole Virus (Pellet)
• 10845357043853: Helix Elite™ Molecular Standards Inactivated SARS-CoV-2 B.1.1.7 Whole Virus (Swab)
• 10845357043846: Helix Elite™ Molecular Standards Inactivated SARS-CoV-2 B.1.1.7 Whole Virus (Pellet)
• 10845357043754: Helix Elite™ Molecular Standards SARS-CoV-2 Whole Virus Antigen Control (Swab)
• 10845357043587: Helix Elite™ Molecular Standards Inactivated Zika Virus
• 10845357044324: Helix Elite™ Molecular Standards Inactivated Negative Blank Control