FDA Registration
Active
🇨🇳 China
Phase Scientific (Shenzhen) Company Limited
Reg #: 3027518847
·
FEI: 3027518847
·
Expires 2026
Products
8
Proprietary Names
8
Establishment Types
2
Classifications
8
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Registration Details
- Registration Name
- Phase Scientific (Shenzhen) Company Limited
- Registration Number
- 3027518847
- FEI Number
- 3027518847
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 201, 301, No.3 3B, Hengtaiyu Bldg, Tangwei Community, Fenghuang Street, Guangming District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K150022
Owner / Operator
- Firm Name
- Phase Scientific International Limited
- Operator Number
- 10083165
- Address
- 1/F. Building 22E Phase 3, Hong Kong Science Park
- City
- Shatin NT
- State
- HK-NOTA
- Postal Code
- 00000
- Country
- HK
- Correspondent
- Ricky Chiu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 2025-01-15 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2025-01-27 |
| Urine Collection Kit (Excludes Hiv Testing) | OIE | Class 1 | Pathology | No | 2024-04-10 |
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2024-04-10 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2025-05-16 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2025-05-16 |
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2025-01-27 |
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2021-10-29 |
Proprietary Names
HR HPV Master Mix
HR HPV Enzyme Mix
INDICAID Urine Collection Kit
Phasify Max Total DNA Extraction Kit
INDICAID HCG EARLY RESULT PREGNANCY TEST STRIP
HR HPV Controls
INDICAID COVID-19 Rapid Antigen Test
INDICAID COVID-19 Rapid Antigen At-Home Test
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device