MedicalSystem Biotechnology Co., Ltd.
⚠️ Moderate Risk
FEI: 3013654096 • Ningbo, Zhejiang • CHINA
FEI Number
3013654096
Location
Ningbo, Zhejiang
Country
CHINAAddress
No. 299 Qiming South Road, Yinzhou District, Ningbo, Zhejiang, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/29/2021 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 8/6/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | Division of Southeast Imports (DSEI) | |
| 7/14/2020 | 81MVUREAGENTS, SPECIFIC, ANALYTE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/1/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 6/23/2020 | 83OTGNON-SARS CORONAVIRUS MULTIPLEX NUCLEIC ACID ASSAY | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 6/18/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | Division of Southeast Imports (DSEI) | |
| 6/16/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/12/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/5/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/1/2020 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | Division of Southeast Imports (DSEI) | |
| 5/4/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 84RX DEVICE | Division of Southeast Imports (DSEI) |
| 4/30/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 84RX DEVICE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MedicalSystem Biotechnology Co., Ltd.'s FDA import refusal history?
MedicalSystem Biotechnology Co., Ltd. (FEI: 3013654096) has 12 FDA import refusal record(s) in our database, spanning from 4/30/2020 to 3/29/2021.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. MedicalSystem Biotechnology Co., Ltd.'s FEI number is 3013654096.
What types of violations has MedicalSystem Biotechnology Co., Ltd. received?
MedicalSystem Biotechnology Co., Ltd. has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about MedicalSystem Biotechnology Co., Ltd. come from?
All FDA import refusal data for MedicalSystem Biotechnology Co., Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.