| Primary Device ID | 50742860100685 |
| NIH Device Record Key | 087f76c0-2ae6-4f23-bd5b-862e2292f5d9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OSOM BVBlue Transport Swabs |
| Version Model Number | 186 |
| Company DUNS | 966812344 |
| Company Name | SEKISUI DIAGNOSTICS, LLC |
| Device Count | 30 |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00742860100680 [Primary] |
| GS1 | 10742860100687 [Unit of Use] |
| GS1 | 50742860100685 [Package] Contains: 00742860100680 Package: Case [24 Units] In Commercial Distribution |
| JTR | Kit, Quality Control For Culture Media |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-03 |
| Device Publish Date | 2026-02-23 |
| 50742860100685 - OSOM BVBlue Transport Swabs | 2026-03-03OSOM BVBlue Transport Swab Set |
| 50742860100685 - OSOM BVBlue Transport Swabs | 2026-03-03 OSOM BVBlue Transport Swab Set |
| 10742860100670 - OSOM COVID-19 Test | 2026-01-27 OSOM COVID-19 Test |
| 10742860100052 - OSOM BV Blue 25T Kit | 2026-01-06 |
| 00742860100062 - OSOM BV Blue Control Kit | 2026-01-06 |
| 00742860000065 - OSOM Flu SARS-CoV-2 Combo Test | 2025-12-23 OSOM Flu SARS-CoV-2 Combo Test |
| 10742860100663 - OSOM RSV Test Home | 2025-05-27 OSOM RSV Test |
| 00628063401291 - Acetaminophen | 2023-05-16 |
| 00628063401307 - Acetaminophen Calibrator | 2023-05-16 |