| Primary Device ID | 06938444980036 |
| NIH Device Record Key | 643edb59-547a-41d6-a865-a5b5f2cd453b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DAVID |
| Version Model Number | RH-LH-B |
| Catalog Number | RH-LH-B |
| Company DUNS | 545868502 |
| Company Name | Runbio Biotech Co., Ltd. |
| 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 | 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 |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06938444980036 [Primary] |
| NGE | Test, Luteinizing Hormone (Lh), Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-02-21 |
| Device Publish Date | 2016-05-11 |
| 06938444980036 | The David Ovulation Test (Urine) is a self-testing rapid chromatographic immunoassay for the qua |
| 06938444982283 | The convenience kit is consisiting of 8 ovulation test midstrems and 2 pregnancy test midstrems. |
| 06938444982276 | The convenience kit is consisiting of 50 ovulation test strips and 25 pregnancy test strips . |
| 06938444982269 | This product is intended for the qualitative determination of human chorionic gonadotropin (hCG) |
| 06938444982412 | The convenience kit is consisiting of 30 ovulation test strips and 10 pregnancy test strips . |
| 06938444982610 | DAVID Pregnancy Test is intended for the qualitative determination of human chorionic gonadotrop |
| 06938444982603 | DAVID Ovulation & Pregnancy Test is consisiting of 90 ovulation test strips and 30 pregnancy tes |
| 06938444982641 | DAVID Ovulation & Pregnancy Test Kit is consisiting of 40 ovulation test strips, 10 pregnancy te |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
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Slingshot USA, LLC 2024-01-17 |
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Linus Technology, Inc. 2023-11-13 |