| Primary Device ID | 56952062778160 |
| NIH Device Record Key | 50eff537-ef2a-4544-8c4f-a313167b9ebc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HCG Home Use Pregnancy Test Midstream (Colloidal Gold) |
| Version Model Number | Midstream,5PCS/BOX |
| Company DUNS | 546403492 |
| Company Name | ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD |
| Device Count | 5 |
| 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 | true |
| 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 | 06952062778165 [Primary] |
| GS1 | 56952062778160 [Unit of Use] |
| JHI | Visual, Pregnancy Hcg, Prescription Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-20 |
| Device Publish Date | 2025-02-12 |
| 06952062712657 - Luteinizing Hormone (LH) Ovulation test | 2026-03-30 LH Ovulation Test (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of Luteinising Hormone ( |
| 06952062712664 - Follicle-Stimulating Hormone (FSH) Menopause test | 2026-03-30 This product is used for qualitative detection of Follicle-Stimulating Hormone (FSH) in the urine for women who are preparing fo |
| 06952062712671 - Luteinizing Hormone (LH) Ovulation test | 2026-03-30 LH Ovulation Test (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of Luteinising Hormone ( |
| 06952062712688 - Follicle-Stimulating Hormone (FSH) Menopause test | 2026-03-30 This product is used for qualitative detection of Follicle-Stimulating Hormone (FSH) in the urine for women who are preparing fo |
| 56952062778160 - HCG Home Use Pregnancy Test Midstream (Colloidal Gold) | 2025-02-20The HCG Home Use Pregnancy Test Midstream (Colloidal Gold) is a rapid chromatographic immunoassay for thequalitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. |
| 56952062778160 - HCG Home Use Pregnancy Test Midstream (Colloidal Gold) | 2025-02-20 The HCG Home Use Pregnancy Test Midstream (Colloidal Gold) is a rapid chromatographic immunoassay for thequalitative detection o |