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Sign in to claim this brandGuangzhou Pluslife Biotech Co., Ltd
China·CN-MF-000025784
Last updated September 18, 2026
What Guangzhou Pluslife Biotech Co., Ltd makes
Guangzhou Pluslife Biotech Co., Ltd manufactures rapid diagnostic tests for infectious diseases, including lateral flow immunoassays and nucleic acid test cards. Their products detect SARS-CoV-2, influenza A and B, respiratory syncytial virus (RSV), and Streptococcus A, alongside assay controls for quality assurance. The portfolio also includes a portable device, the MiniDock, for processing and reading test results, as well as a thermolysis unit for sample preparation.
The company’s devices are classified under Class A and In Vitro Diagnostic (IVD) General categories, with some products listed in the EU’s eudamed registry. Their products are designed for point-of-care and laboratory use, adhering to regulatory frameworks applicable to diagnostic medical devices. The manufacturer is based in China.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- China
- Address
- No.14 , Baoying Avenue, Huangpu District, Guangzhou, Guangdong, , China
- Website
- www.pluslife.com
- —
- —
- [email protected]
- Phone
- 0086-20-31703986
- PRRC Contact
- Joyce Chan
- EUDAMED SRN
- CN-MF-000025784
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (13)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MiniDock MTB Test | RM1012202-10 | EUDAMED | IVD General | Active |
| Pluslife SARS-CoV-2 Card | RM1010202-10 | EUDAMED | IVD General | Active |
| Pluslife SARS-CoV-2/Influenza A/Influenza B Card | RM1010302-10 | EUDAMED | IVD General | Active |
| Pluslife RSV Card | RM1010902-10 | EUDAMED | IVD General | Active |
| Influenza A/Influenza B/RSV Nucleic Acid Test Card | RM1010402-10 | EUDAMED | IVD General | Active |
| SARS-CoV-2/Influenza A/Influenza B/RSV Nucleic Acid Assay Control | CRM1010302-1 | EUDAMED | IVD General | Active |
| Pluslife Thermolyse | WD002 | EUDAMED | Class A | Active |
| MiniDock Ultra | PM001 Ultra | EUDAMED | Class A | Active |
| Strep A Nucleic Acid Assay Control | CRM1010402-1 | EUDAMED | IVD General | Active |
| Mini Dock | PM001 | EUDAMED | Class A | Active |
| Pluslife Strep A Card | RM1010702-10 | EUDAMED | IVD General | Active |
| Pluslife Dock Pro 8 | PM008 | EUDAMED | Class A | Active |
| Mycobacterium Tuberculosis Nucleic Acid Assay Control | CRM1010602-1 | EUDAMED | IVD General | Active |
Related Companies
Authorised Representatives
Importers
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Authorities
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Guangzhou Pluslife Biotech Co., Ltd has two FDA recall records, both initiated on January 24, 2025. One record is marked as open, while the other is classified. Both involve devices distributed in the U.S. without securing the necessary FDA premarket authorization, such as 510(k) clearance or a Premarket Approval (PMA).
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 24, 2025 | Z-1978-2025 | — | open, classified | Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA). |
| Jan 24, 2025 | Z-1979-2025 | — | open, classified | Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA). |