| Primary Device ID | 20816101022230 |
| NIH Device Record Key | 2afa100d-420f-49fd-8586-e374debac0d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Histoplasma DxSelect™ |
| Version Model Number | EL1700 |
| Company DUNS | 080271715 |
| Company Name | DIASORIN MOLECULAR LLC |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Phone | 562-240-6500 |
| DxTs@focusdx.com | |
| Phone | 562-240-6500 |
| DxTs@focusdx.com | |
| Phone | 562-240-6500 |
| DxTs@focusdx.com | |
| Phone | 562-240-6500 |
| DxTs@focusdx.com | |
| Phone | 562-240-6500 |
| DxTs@focusdx.com | |
| Phone | 562-240-6500 |
| DxTs@focusdx.com | |
| Phone | 562-240-6500 |
| DxTs@focusdx.com | |
| Phone | 562-240-6500 |
| DxTs@focusdx.com | |
| Phone | 562-240-6500 |
| DxTs@focusdx.com | |
| Phone | 562-240-6500 |
| DxTs@focusdx.com | |
| Phone | 562-240-6500 |
| DxTs@focusdx.com | |
| Phone | 562-240-6500 |
| DxTs@focusdx.com | |
| Phone | 562-240-6500 |
| DxTs@focusdx.com | |
| Phone | 562-240-6500 |
| DxTs@focusdx.com | |
| Phone | 562-240-6500 |
| DxTs@focusdx.com | |
| Phone | 562-240-6500 |
| DxTs@focusdx.com | |
| Phone | 562-240-6500 |
| DxTs@focusdx.com | |
| Phone | 562-240-6500 |
| DxTs@focusdx.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 |
| 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 | 20816101022230 [Primary] |
| MIZ | Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-22 |