| Primary Device ID | 10634853000589 |
| NIH Device Record Key | f7f450e3-2f46-4028-b924-b95dbaf8541a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Microorganism Pellets |
| Version Model Number | URI-KIT |
| Catalog Number | URI-KIT |
| 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 |
| 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 |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10634853000589 [Primary] |
| JTR | Kit, quality control for culture media |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-04 |
| Device Publish Date | 2022-09-26 |
| 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 |
| 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 |