| Primary Device ID | 06974246462547 |
| NIH Device Record Key | b2a9094b-dfde-4290-bccd-8bf777f090cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Welcheck HCG Urine Test Midstream |
| Version Model Number | 5 Tests |
| Catalog Number | HCG-1013 |
| Company DUNS | 544349634 |
| Company Name | Safecare Biotech (Hangzhou) Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06974246462547 [Primary] |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-12 |
| Device Publish Date | 2025-08-04 |
| 06974246462547 - Welcheck HCG Urine Test Midstream | 2025-08-12 |
| 06974246462547 - Welcheck HCG Urine Test Midstream | 2025-08-12 |
| 06974246462400 - FIRSTVIEW Luteinizing Hormone Rapid Test Strip | 2025-08-07 |
| 06974246462417 - FIRSTVIEW Luteinizing Hormone Rapid Test Strip | 2025-08-07 |
| 06974246462424 - Exploro Highly Sensitive Urine Drug Test (14-Panel) | 2025-08-07 |
| 06974246462431 - Exploro Highly Sensitive Urine Drug Test (14-Panel) | 2025-08-07 |
| 06974246462448 - Exploro Highly Sensitive Urine Drug Test (14-Panel) | 2025-08-07 |
| 06974246462455 - Exploro Highly Sensitive Urine Drug Test (14-Panel) | 2025-08-07 |
| 06974246462462 - Exploro Highly Sensitive Urine Drug Test (14-Panel) | 2025-08-07 |