Hangzhou AllTest Biotech Co.,Ltd
⚠️ High Risk
FEI: 3012073813 • Hangzhou, Zhejiang • CHINA
FEI Number
3012073813
Location
Hangzhou, Zhejiang
Country
CHINAAddress
No. 550 Yinhai Street, Hangzhou Economic & Technological Area, Hangzhou, Zhejiang, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/17/2025 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | Division of Southeast Imports (DSEI) | |
| 5/30/2025 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | Division of Southeast Imports (DSEI) | |
| 5/6/2025 | 83QYTOVER-THE-COUNTER COVID-19 ANTIGEN TEST | Division of Southeast Imports (DSEI) | |
| 2/11/2025 | 91DJGENZYME IMMUNOASSAY, OPIATES | Division of Southeast Imports (DSEI) | |
| 2/11/2025 | 91JXMENZYME IMMUNOASSAY, BENZODIAZIPINE | Division of Southeast Imports (DSEI) | |
| 8/23/2023 | 91MGXTEST SYSTEM, FOR DRUGS OF ABUSE | Division of West Coast Imports (DWCI) | |
| 7/13/2023 | 91MGXTEST SYSTEM, FOR DRUGS OF ABUSE | Division of West Coast Imports (DWCI) | |
| 6/3/2022 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 5/25/2022 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 3/15/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 3/4/2022 | 88NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS | Division of West Coast Imports (DWCI) | |
| 3/2/2022 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/28/2022 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/16/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 2/7/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 2/2/2022 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | Division of Southeast Imports (DSEI) | |
| 11/1/2021 | 83QMNCOVID-19 MULTI-ANALYTE ANTIGEN DEVICE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/25/2021 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/3/2021 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 1/21/2021 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | Division of West Coast Imports (DWCI) | |
| 1/20/2021 | 91JXMENZYME IMMUNOASSAY, BENZODIAZIPINE | Division of West Coast Imports (DWCI) | |
| 1/15/2021 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/11/2021 | 91JXMENZYME IMMUNOASSAY, BENZODIAZIPINE | Division of West Coast Imports (DWCI) | |
| 11/30/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | Division of Southeast Imports (DSEI) | |
| 9/2/2020 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/21/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/17/2020 | 91DJCTHIN LAYER CHROMATOGRAPHY, METAMPHETAMINE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/29/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/1/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | Division of Southeast Imports (DSEI) | |
| 3/16/2020 | 91PFTREAGENTS FOR MOLECULAR DIAGNOSTIC TEST SYSTEMS | Division of Southeast Imports (DSEI) | |
| 3/16/2020 | 91PFTREAGENTS FOR MOLECULAR DIAGNOSTIC TEST SYSTEMS | Division of Southeast Imports (DSEI) | |
| 3/16/2020 | 91PFTREAGENTS FOR MOLECULAR DIAGNOSTIC TEST SYSTEMS | Division of Southeast Imports (DSEI) | |
| 3/16/2020 | 91PFTREAGENTS FOR MOLECULAR DIAGNOSTIC TEST SYSTEMS | Division of Southeast Imports (DSEI) | |
| 3/16/2020 | 91PFTREAGENTS FOR MOLECULAR DIAGNOSTIC TEST SYSTEMS | Division of Southeast Imports (DSEI) | |
| 3/16/2020 | 91PFTREAGENTS FOR MOLECULAR DIAGNOSTIC TEST SYSTEMS | Division of Southeast Imports (DSEI) | |
| 3/16/2020 | 91PFTREAGENTS FOR MOLECULAR DIAGNOSTIC TEST SYSTEMS | Division of Southeast Imports (DSEI) | |
| 3/16/2020 | 91NGATEST, FOLLICLE STIMULATING HORMONE (FSH), OVER THE COUNTER | Division of Southeast Imports (DSEI) | |
| 3/16/2020 | 85LHDDEVICE, FERTILITY DIAGNOSTIC, PROCEPTIVE | Division of Southeast Imports (DSEI) | |
| 3/16/2020 | 85LHDDEVICE, FERTILITY DIAGNOSTIC, PROCEPTIVE | Division of Southeast Imports (DSEI) | |
| 10/15/2018 | 83JSXKIT, IDENTIFICATION, NEISSERIA GONORRHOEAE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Hangzhou AllTest Biotech Co.,Ltd's FDA import refusal history?
Hangzhou AllTest Biotech Co.,Ltd (FEI: 3012073813) has 40 FDA import refusal record(s) in our database, spanning from 10/15/2018 to 6/17/2025.
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. Hangzhou AllTest Biotech Co.,Ltd's FEI number is 3012073813.
What types of violations has Hangzhou AllTest Biotech Co.,Ltd received?
Hangzhou AllTest Biotech Co.,Ltd has been cited for 7 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 Hangzhou AllTest Biotech Co.,Ltd come from?
All FDA import refusal data for Hangzhou AllTest Biotech 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.