| Primary Device ID | 20816101027037 |
| NIH Device Record Key | 3250fa79-267f-4298-acb8-35d479406c6a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Simplexa COVID-19 Positive Control Pack |
| Version Model Number | MOL4160 |
| Catalog Number | MOL4160 |
| 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 | 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 | 5622406500 |
| TS.molecular@diasorin.com | |
| Phone | 5622406500 |
| TS.molecular@diasorin.com | |
| Phone | 5622406500 |
| TS.molecular@diasorin.com | |
| Phone | 5622406500 |
| TS.molecular@diasorin.com | |
| Phone | 5622406500 |
| TS.molecular@diasorin.com | |
| Phone | 5622406500 |
| TS.molecular@diasorin.com | |
| Phone | 5622406500 |
| TS.molecular@diasorin.com | |
| Phone | 5622406500 |
| TS.molecular@diasorin.com | |
| Phone | 5622406500 |
| TS.molecular@diasorin.com | |
| Phone | 5622406500 |
| TS.molecular@diasorin.com | |
| Phone | 5622406500 |
| TS.molecular@diasorin.com | |
| Phone | 5622406500 |
| TS.molecular@diasorin.com | |
| Phone | 5622406500 |
| TS.molecular@diasorin.com | |
| Phone | 5622406500 |
| TS.molecular@diasorin.com | |
| Phone | 5622406500 |
| TS.molecular@diasorin.com | |
| Phone | 5622406500 |
| TS.molecular@diasorin.com | |
| Phone | 5622406500 |
| TS.molecular@diasorin.com | |
| Phone | 5622406500 |
| TS.molecular@diasorin.com |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 20816101027037 [Primary] |
| QQX | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-26 |
| Device Publish Date | 2023-06-16 |