Helix Elite™ Molecular Standards: Inactivated Standard HE0068AG
GUDID 10845357043754
Helix Elite™ Molecular Standards SARS-CoV-2 Whole Virus Antigen Control (Swab)
MICROBIOLOGICS INC.
SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control SARS-CoV-2 antigen IVD, control| Primary Device ID | 10845357043754 |
| NIH Device Record Key | 6ab721ab-4c38-4eda-8f05-b08ac4f667c7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Helix Elite™ Molecular Standards: Inactivated Standard |
| Version Model Number | HE0068AG |
| Catalog Number | HE0068AG |
| 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 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| techsupport@microbiologics.com | |
| Phone | +1(320)253-7400 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10845357043754 [Primary] |
FDA Product Code
| MJZ | Kit, Direct Antigen, Positive Control |
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 | 2022-02-24 |
| Device Publish Date | 2022-02-16 |
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 |
Trademark Results [Helix Elite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HELIX ELITE 86199844 5082578 Live/Registered |
Microbiologics, Inc. 2014-02-21 |
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