NATALIST RH-HCG-B
GUDID 00850014758363
NATALIST EARLY Pregnancy Test is a self-testing rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. There are 4pcs of midstream in each box.
Runbio Biotech Co., Ltd.
Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid| Primary Device ID | 00850014758363 |
| NIH Device Record Key | 84e1f404-25d1-4707-a98a-293039597da2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NATALIST |
| Version Model Number | 8363 |
| Catalog Number | RH-HCG-B |
| Company DUNS | 545868502 |
| Company Name | Runbio Biotech Co., Ltd. |
| Device Count | 4 |
| 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 |
Customer Support Contacts
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com | |
| Phone | 1-843-5807572 |
| liz@natalist.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850014758127 [Unit of Use] |
| GS1 | 00850014758363 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K181551
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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-02 |
| Device Publish Date | 2019-12-25 |
Devices Manufactured by Runbio Biotech Co., Ltd.
| 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 |
Trademark Results [NATALIST]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NATALIST 88748273 not registered Live/Pending |
Baby Someday Inc. 2020-01-06 |
 NATALIST 88673768 not registered Live/Pending |
Baby Someday Inc. 2019-10-30 |
 NATALIST 88673762 not registered Live/Pending |
Baby Someday Inc. 2019-10-30 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.