| Primary Device ID | 08053326011771 |
| NIH Device Record Key | 44b5cd73-24f0-418f-9377-7f8959b79aaf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LBM CABroth |
| Version Model Number | 4U161N |
| Catalog Number | 4U161N |
| Company DUNS | 428981112 |
| Company Name | COPAN ITALIA SPA |
| Device Count | 50 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08053326011771 [Unit of Use] |
| GS1 | 38053326011772 [Primary] |
| JSD | Culture Media, Selective Broth |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-30 |
| Device Publish Date | 2025-09-22 |
| 08053326011771 - LBM CABroth | 2025-09-30 |
| 08053326011771 - LBM CABroth | 2025-09-30 |
| 58053326011653 - CLASSIQSwab | 2025-07-11 |
| 58053326011660 - CLASSIQSwabs™ FLOQ Swabs® | 2025-07-11 |
| 58053326009551 - Copan Universal Transport Medium (UTM-RT) System | 2025-06-05 Copan Universal Transport Medium (UTM-RT) System 3ml |
| 18053326009867 - Copan Universal Transport Medium (UTM-RT) System | 2025-06-05 Copan Universal Transport Medium (UTM-RT) System 3ml + One flexible flocked swab, breaking point 100 mm |
| 18053326010283 - Copan Universal Transport Medium (UTM-RT) System | 2025-06-05 Copan Universal Transport Medium (UTM-RT) System 3ml + One regular flocked swab, breaking point 80 mm |
| 08053326010446 - Copan Universal Transport Medium (UTM-RT) System | 2025-06-05 Copan Universal Transport Medium (UTM-RT) System 3 ml |
| 58053326011073 - Copan Universal Transport Medium (UTM-RT) System | 2025-06-05 Copan Universal Transport Medium (UTM-RT) System 3ml + One minitip flocked swab, breaking point 80 mm |