GenaCheck Vaginal Ph Screening Test
Catalogue number RA9-E02303, listed by Genabio Diagnostics Inc, United States, under Paper, Obstetric Ph. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (6), Jilin (5), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Changchun Merydi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| Jilin Hongyi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| Safecare Biotech(Hangzhou)Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 22 |
| Henso Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Changchun LYZ Technology Co., Ltd. | Changchun | Jilin | Manufacturer | 16 |
| Jilin Test BIO-Electron Co., Ltd. | Changchun | Jilin | Manufacturer | 9 |
| Zhejiang E-WAY Healthcare Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
| Xiamen MK Health Care Product Co., Ltd. | Xiamen | Fujian | Manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Paper, Obstetric Ph
Record
| Listed by | Genabio Diagnostics Inc, United States |
|---|---|
| FDA product code | LNW |
| Device type | Paper, Obstetric Ph |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1550 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-08-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| RA9-E02303 | 3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Exploro Vaginal Health pH Test Device | Safecare Biotech(Hangzhou)Co., Ltd. | 6 |
| Vaginal PH Rapid Test Cassette | Safecare Biotech(Hangzhou)Co., Ltd. | 3 |
| Welcheck Vaginal PH Rapid Test Cassette | Safecare Biotech(Hangzhou)Co., Ltd. | 3 |
| T Testahead Vaginal PH Rapid Test Cassette | Safecare Biotech(Hangzhou)Co., Ltd. | 2 |
| Safecare Vaginal PH Rapid Test Cassette | Safecare Biotech(Hangzhou)Co., Ltd. | 2 |
| Easy@home Feminine Vaginal pH Test Strip(30 tests) | Easy Healthcare Corporation | 1 |
| Winx Health Inc | Get Stix Inc. | 1 |
| Gynex | Gynex Corporation | 1 |
| Testahead Vaginal PH Rapid Test Cassette | Safecare Biotech(Hangzhou)Co., Ltd. | 1 |
| Easy@home Feminine Vaginal pH Test Strip(10 tests) | Easy Healthcare Corporation | 1 |
| Teco Diagnostics Vaginal pH Screening Kit | Teco Diagnostics | 1 |
| McKesson | Mckesson Medical-Surgical Inc. | 1 |
Showing 12 of 13. All products under Paper, Obstetric Ph
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.