Clearblue
The Clearblue Period Cycle Tracker App is a free mobile phone app which uses the mobile phone’s camera to capture the result of compatible lateral flow test strips, such as the Clearblue…
The Clearblue Period Cycle Tracker App is a free mobile phone app which uses the mobile phone’s camera to capture the result of compatible lateral flow test strips, such as the Clearblue Smart Ovulation Test (SOT). The test sticks and the app work as a system.
Who Else Makes It
Concentrated in Zhejiang (14), Jiangsu (4), Guangdong (4). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Core Technology Co., Ltd. | Changping District | Beijing | Contract manufacturer | 14 |
| Hangzhou Careomedic Tech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 5 |
| Abbott Diagnostics (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Baoding Abiores Chip Co., Ltd. | Baoding | Hebei | Contract manufacturer | 1 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
Showing 12 of 38. All 38 manufacturers in China registered for Test, Luteinizing Hormone (Lh), Over The Counter
Record
| Listed by | SPD Swiss Precision Diagnostics Gmbh, Switzerland |
|---|---|
| FDA product code | NGE |
| Device type | Test, Luteinizing Hormone (Lh), Over The Counter |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1485 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-06-07 |
| Record revised | 2024-03-25 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 2 to 30 °C |
| Packaging | Shipping case of 6, shipping case of 12, shipping case of 2, shipper of 24, shippping case of 6, shipper of 6 |
| Distribution end date | 2025-11-28 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Period Cycle Tracker- CBApp-1 | In distribution | ||
| Fertility Monitor | In distribution | ||
| Advanced Digital Ovulation Test Kit | In distribution | ||
| Smart Ovulation Test | 50 | In distribution | |
| Digital Ovulation Test | 10 | In distribution | |
| Digital Ovulation Test | 30 | In distribution | |
| Smart Ovulation Test | 10 | In distribution | |
| Fertility Monitor Test Sticks | 30 | In distribution | |
| Smart Ovulation Test | 20 | In distribution | |
| Digital Ovulation Test | 40 | In distribution | |
| Advanced Digital Ovulation Test Kit | In distribution | ||
| Advanced Digital Ovulation Test | 10 | Withdrawn | |
| Advanced Period Tracker | 18 | Withdrawn | |
| Advanced Digital Ovulation Test | 20 | Withdrawn | |
| Advanced Ovulation Kit | Withdrawn | ||
| Ovulation Kit | Withdrawn | ||
| Birth Control Kit | Withdrawn | ||
| Digital Ovulation Test | 15 | Withdrawn | |
| Digital Pregnancy Test | 20 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ferticare | Weihai Kangzhou Biotechnology Engineering Co., Ltd. | 9 |
| Wondfo | Wondfo USA Co., Ltd. | 7 |
| One Step® LH Ovulation Rapid Test Dipstick (Urine) | Guangzhou Decheng Biotechnology Co., Ltd. | 6 |
| Amazewell | Guangzhou Decheng Biotechnology Co., Ltd. | 5 |
| iProvèn | Masena Invest B.V. | 5 |
| Firstview Luteinizing Hormone Rapid Test Strip | Safecare Biotech(Hangzhou)Co., Ltd. | 4 |
| Macro & Micro-Test LH Test | Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | 4 |
| Egens | Nantong Egens Biology Technic Co., Ltd. | 4 |
| MissLan | Guangzhou Decheng Biotechnology Co., Ltd. | 4 |
| VeriQuick | Fourstar Group | 3 |
| Modern Fertility Ovulation Test | Modern Healthcare Corp. | 3 |
| LittleBegin | Hangzhou Laihe Biotech Co., Ltd. | 3 |
Showing 12 of 69. All products under Test, Luteinizing Hormone (Lh), Over The Counter
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.