| Primary Device ID | 04250306300915 |
| NIH Device Record Key | bcf652c8-4829-45fc-9ade-da2ee9a13c1d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PSP SalivaGene DNA Kit |
| Version Model Number | 50 prep |
| Catalog Number | 1035200200 |
| Company DUNS | 331869789 |
| Company Name | Invitek Molecular GmbH |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04250306300915 [Primary] |
| PPM | General Purpose Reagent |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-10 |
| Device Publish Date | 2024-09-02 |
| 04250306301219 - SalivaGene Collector | 2025-02-20 |
| 04250306300212 - InviTrap Spin Universal RNA Kit (50) | 2025-01-28 Kit designed for the isolation of RNA from various samples |
| 04250306300229 - InviTrap Spin Universal RNA Kit (250) | 2025-01-28 Kit design for isolation of RNA from various samples. |
| 04250306300311 - RTP Pathogen Kit (50) | 2025-01-28 |
| 04250306300328 - RTP Pathogen Kit (250) | 2025-01-28 |
| 04250306300410 - PSP Spin Stool DNA Basic Kit (50) | 2025-01-28 |
| 04250306300427 - PSP Spin Stool DNA Basic Kit (250) | 2025-01-28 |
| 04250306300922 - PSP SalivaGene DNA Kit (250) | 2025-01-28 |