| Primary Device ID | 10850054552041 |
| NIH Device Record Key | 82177368-ce9b-40cf-a00c-43747bde395f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | US Paramed Collection Oral Fluid Kit |
| Version Model Number | Exempt |
| Company DUNS | 189222334 |
| Company Name | Quest Diagnostics |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | true |
| 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 | 00850054552044 [Primary] |
| GS1 | 10850054552041 [Package] Contains: 00850054552044 Package: [5 Units] In Commercial Distribution |
| KDT | Container, Specimen Mailer And Storage, Sterile |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-09 |
| Device Publish Date | 2024-05-01 |
| 00850054552068 - K-QUE-ACT-001 REV002 | 2026-03-05 QCard Blood Collection Kit (WHS) |
| 00850054552075 - K-QUE-ACT-003 REV002 | 2026-03-05 QCard Collection Kit (WHS) |
| 00850054552082 - K-QUE-ACT-004 REV002 | 2026-03-05 QCard Collection Kit |
| 00850054552099 - K-QUE-ACT-005 REV002 | 2026-03-05 QCard Collection Kit (WHS) |
| 00850054552105 - K-QUE-ACT-006 REV001 | 2026-03-05 QCard Collection Kit (WHS) |
| 00850054552112 - K-QUE-ACT-007 REV000 | 2026-03-05 QCard Collection Kit (WHS) |
| 00850054552129 - K-QUE-KED-001 REV000 | 2026-03-05 QCard Collection Kit |
| 10850054552034 - US Blood And Urine Kit | 2024-05-09 US Blood And Urine Kit |