Helix Elite™ Molecular Standards: Synthetic Standard HE0063S
GUDID 10845357043556
Helix Elite™ Molecular Standards SARS-CoV-2 Process Control (Swab)
MICROBIOLOGICS INC.
SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control| Primary Device ID | 10845357043556 |
| NIH Device Record Key | ca817fd0-d652-45d7-89f2-8c08746b49f7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Helix Elite™ Molecular Standards: Synthetic Standard |
| Version Model Number | HE0063S |
| Catalog Number | HE0063S |
| 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
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 |
| 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 |
| 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 | 10845357043556 [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 | 2020-12-25 |
| Device Publish Date | 2020-12-17 |
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) |
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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