| Primary Device ID | 16970429840154 |
| NIH Device Record Key | 745c8bc7-c3c3-4c90-a17c-a6be3ba6200f |
| Commercial Distribution Discontinuation | 2019-12-26 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | HCG TEST STRIP |
| Version Model Number | HCG3.5 |
| Company DUNS | 421302978 |
| Company Name | Co-Innovation Biotech 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 | 06970429840157 [Primary] |
| GS1 | 16970429840154 [Package] Contains: 06970429840157 Package: [100 Units] Discontinued: 2019-12-26 Not in Commercial Distribution |
| GS1 | 26970429840151 [Package] Package: [100 Units] Discontinued: 2019-12-26 Not in Commercial Distribution |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-07-06 |
| Device Publish Date | 2019-12-25 |
| 16970429843414 - co-innovation | 2025-05-27 |
| 16970429843315 - co-innovation | 2024-08-28 |
| 16970429841342 - DTPM | 2023-12-18 |
| 16970429841632 - DTPM | 2023-12-18 |
| 16970429840154 - HCG TEST STRIP | 2023-07-06 |
| 16970429840154 - HCG TEST STRIP | 2023-07-06 |
| 16970429840178 - co-innovation | 2023-05-08 |
| 16970429841816 - co-innovation | 2022-11-21 Rapid Multi-drug Test Cup |
| 16970429841441 - co-innovation | 2022-01-24 14P Drug Test |