| Primary Device ID | 00868586000285 |
| NIH Device Record Key | 50e1b68e-1acb-48f5-a772-f3b6ec3ccd47 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | General Purpose Reagent Delayed Semen Analysis Media |
| Version Model Number | PPM |
| 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 | 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 | 00868586000285 [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 | 2023-07-19 |
| Device Publish Date | 2023-07-11 |
| 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 |