| Primary Device ID | 30816101025092 |
| NIH Device Record Key | 4c1e0b56-6fb0-4169-96bf-c0ace5709289 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Direct Amplification Disc Kit |
| Version Model Number | MOL1455 |
| Company DUNS | 080271715 |
| Company Name | DIASORIN MOLECULAR LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 562-240-6500 |
| DxTs@FocusDx.com | |
| Phone | 562-240-6500 |
| DxTs@FocusDx.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 30816101025092 [Primary] |
| OOI | Real Time Nucleic Acid Amplification System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-14 |