INVBIO
GUDID 06938444981316
HCG Pregnancy Test Strip is a self-testing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. It is for over-the-counter use. It consists of 25 strips.
Equinox Biotech Co., Ltd.
Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid| Primary Device ID | 06938444981316 |
| NIH Device Record Key | 2234c1f6-ce10-413a-828f-8ce399602726 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INVBIO |
| Version Model Number | 81316 |
| Company DUNS | 545868502 |
| Company Name | Equinox 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 | true |
| 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 |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06938444981316 [Primary] |
FDA Product Code
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-11-23 |
| Device Publish Date | 2019-06-01 |
On-Brand Devices [INVBIO]
| 06938444981323 | The convenience kit consisiting of 50 ovulation test strips 3mm and 20 pregnancy test strips 3mm |
| 06938444981316 | HCG Pregnancy Test Strip is a self-testing immunoassay designed for the qualitative determinatio |
Trademark Results [INVBIO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INVBIO 88309698 not registered Dead/Abandoned |
Beijing Yinuowei Biotechnology Co., Ltd. 2019-02-21 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.