Phase Scientific (Shenzhen) Company Limited
Registered establishment in Shenzhen, Guangdong, China. 8 device types.
Phase Scientific (Shenzhen) Company Limited is a repacker / relabeller holding a current FDA establishment registration. The registration covers General Purpose Reagent, Reagents, Specific, Analyte and 6 other device types. Its earliest product listing with the FDA dates from 2021.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3027518847 |
| FEI number | 3027518847 |
| Establishment type | Repacker / relabeller, Manufacturer |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Room 201, 301, No.3 3B, Hengtaiyu Bldg, Tangwei Community, Fenghuang Street, Guangming District |
| Postal code | 518107 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Clinical Sample Concentrator | Class 1 | Phasify Max Total DNA Extraction Kit | 2024 | 27 |
| Coronavirus Antigen Detection Test System. | Class N | INDICAID COVID-19 Rapid Antigen At-Home Test, INDICAID COVID-19 Rapid Antigen Test | 2021 | 12 |
| General Purpose Reagent | Class 1 | HR HPV Enzyme Mix | 2025 | 30 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | Class 2 | Indicaid™ HCG Early Result Pregnancy Test Strip | 2025 | 30 |
| Multi-Analyte Controls Unassayed | Class 1 | HR HPV Controls | 2025 | 2 |
| Reagents, Specific, Analyte | Class 1 | HR HPV Master Mix | 2025 | 6 |
| Urine Collection Kit (Excludes Hiv Testing) | Class 1 | INDICAID Urine Collection Kit | 2024 | 7 |
| Visual, Pregnancy Hcg, Prescription Use | Class 2 | Indicaid™ HCG Early Result Pregnancy Test Strip | 2025 | 16 |
Clearances
No clearance names Phase Scientific (Shenzhen) Company Limited as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K150022 | 2015-08-07 | LCX | Traditional | Guangzhou Wondfo Biotech Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Employees | 201-500 |
|---|---|
| Main products | COVID-19 rapid antigen test, cfDNA extraction kit, Diagnostic tools |
| Certifications | FDA EUA, China NMPA |
| Export markets | Global |
Nearby Manufacturers
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.
The manufacturer named here can complete this record.