Data / Medical devices / China / Phase Scientific (Shenzhen) Company Limited
Phase Scientific (Shenzhen) Company Limited: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Phase Scientific (Shenzhen) Company Limited is registered with the FDA (registration 3027518847) in Shenzhen Guangdong, China. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 7, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027518847
- Address
- Room 201, 301, No.3 3B, Hengtaiyu Bldg, Tangwei Community, Fenghuang Street, Guangming District, Shenzhen Guangdong, China, 518107
- Owner or operator
- Phase Scientific International Limited (10083165)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- October 29, 2021
- Registered through
- 2026
- Brand names listed
- HR HPV Controls, HR HPV Enzyme Mix, HR HPV Master Mix, INDICAID COVID-19 Rapid Antigen At-Home Test, INDICAID COVID-19 Rapid Antigen Test, INDICAID Urine Collection Kit, INDICAID HCG EARLY RESULT PREGNANCY TEST STRIP, Phasify Max Total DNA Extraction Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Sample Concentrator | JJH | 1 | Manufacturer | accessdata.fda.gov |
| Coronavirus Antigen Detection Test System. | QKP | N | Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Manufacturer | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Multi-Analyte Controls Unassayed | OHQ | 1 | Manufacturer | accessdata.fda.gov |
| Reagents, Specific, Analyte | MVU | 1 | Manufacturer | accessdata.fda.gov |
| Urine Collection Kit (Excludes Hiv Testing) | OIE | 1 | Manufacturer | accessdata.fda.gov |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 7, 2015 | K150022 | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream | LCX | Substantially Equivalent | Guangzhou Wondfo Biotech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Clinical Sample Concentrator
- All makers of Multi-Analyte Controls Unassayed
- All makers of Coronavirus Antigen Detection Test System.
- All makers of Urine Collection Kit (Excludes Hiv Testing)
- All makers of General Purpose Reagent
- All makers of Visual, Pregnancy Hcg, Prescription Use
Updated August 7, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.