| Primary Device ID | 06938444980043 |
| NIH Device Record Key | af0523f9-f9ea-4058-89ff-7c38aca46ff7 |
| Commercial Distribution Discontinuation | 2016-08-08 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | DAVID Ovulation Test (Urine) |
| Version Model Number | 80043 |
| Catalog Number | RH-LH-S01 |
| Company DUNS | 545868502 |
| Company Name | Runbio Biotech Co., Ltd. |
| Device Count | 50 |
| 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 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 06938444980043 [Primary] |
| GS1 | 06938444980111 [Unit of Use] |
| 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 | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-08 |
| 06938444982641 - DAVID | 2022-07-25 DAVID Ovulation & Pregnancy Test Kit is consisiting of 40 ovulation test strips, 10 pregnancy test strips and 2 pregnancy crysta |
| 06938444982603 - DAVID | 2022-07-11 DAVID Ovulation & Pregnancy Test is consisiting of 90 ovulation test strips and 30 pregnancy test strips . |
| 06938444982610 - DAVID | 2022-07-11 DAVID Pregnancy Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in |
| 00850014758431 - NATALIST PREGNANCY TEST STRIP 15 COUNT | 2022-02-04 NATALIST PREGNANCY TEST STRIP 15 COUNT is intended for the qualitative determination of human chorionic gonadotropin (hCG) in th |
| 06938444982498 - OT80-Beurer Ovulation Predictor and Fertility Tracking Kit | 2021-07-08 The product consist of 15 ovulation test strips, 15 FSH test strips and 2 pregnancy test strips. |
| 06938444982481 - DAVID Ovulation Test Strip | 2021-06-09 DAVID Ovulation Test Strip is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizin |
| 06938444982412 - DAVID | 2021-05-04 The convenience kit is consisiting of 30 ovulation test strips and 10 pregnancy test strips . |
| 00850014758042 - NATALIST OVULATION TEST MIDSTREAM 10 COUNT | 2021-01-11 NATALIST OVULATION TEST MIDSTREAM 10 COUNT is a self-testing rapid chromatographic immunoassay for the qualitative detection of |