| Primary Device ID | 04260759850172 |
| NIH Device Record Key | 4a08ff86-c991-406f-bc8c-8df1bf54c25e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EchoLUTION Viral RNA/DNA Kit (2 x 48) |
| Version Model Number | 012-051-002-Dx |
| Catalog Number | 012-051-002-Dx |
| Company DUNS | 314351906 |
| Company Name | BioEcho Life Sciences 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260759850172 [Primary] |
| JJH | Clinical Sample Concentrator |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-24 |
| Device Publish Date | 2023-11-16 |
| 04260759850172 - EchoLUTION Viral RNA/DNA Kit (2 x 48) | 2023-11-24 |
| 04260759850172 - EchoLUTION Viral RNA/DNA Kit (2 x 48) | 2023-11-24 |
| 04260759850189 - EchoLUTION Viral RNA/DNA Kit (8 x 48) | 2023-11-24 |
| 04260759850196 - EchoLUTION Viral RNA/DNA Kit (16 x 48) | 2023-11-24 |
| 04260759850202 - EchoLUTION Viral RNA/DNA Kit (2 x 96) | 2023-11-24 |
| 04260759850219 - EchoLUTION Viral RNA/DNA Kit (8 x 96) | 2023-11-24 |
| 04260759850226 - EchoLUTION Viral RNA/DNA Kit (16 x 96) | 2023-11-24 |