| Primary Device ID | 10816101022288 |
| NIH Device Record Key | 1cfc2000-8ca0-4c96-afea-dbebb05d33f4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | West Nile Virus IgM Capture DxSelect™ IgM Cutoff Calibrator (0.3 mL) |
| Version Model Number | EL0303 |
| Catalog Number | EL0303 |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | true |
| OTC Over-The-Counter | false |
| 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 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 | 10816101022288 [Primary] |
| NOP | Elisa, Antibody, West Nile Virus |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-07-05 |
| Device Publish Date | 2017-05-16 |
| 10816101022271 - West Nile Virus IgM Capture DxSelect™ Anti-Flavivirus Conjugate | 2024-07-05 |
| 10816101022288 - West Nile Virus IgM Capture DxSelect™ IgM Cutoff Calibrator (0.3 mL) | 2024-07-05 |
| 10816101022288 - West Nile Virus IgM Capture DxSelect™ IgM Cutoff Calibrator (0.3 mL) | 2024-07-05 |
| 10816101022301 - DxSelect™ - Stop Reagent | 2024-07-05 |
| 10816101022318 - West Nile Virus IgG DxSelect™ - IgG Conjugate | 2024-07-05 |
| 10816101021014 - HSV-1 AND HSV-2 Differentiation Immunoblot IgG Antigen Strips | 2024-07-04 |
| 10816101021021 - HSV-1 and HSV-2 Immunoblot IgG Cutoff/Positive Control | 2024-07-04 |
| 10816101021038 - HSV-1 and HSV-2 Immunoblot IgG Negative Control | 2024-07-04 |
| 10816101022042 - West Nile Virus DxSelect™ Negative Control | 2024-07-04 |