Hangzhou Biotest Biotech Co.,Ltd.

FDA Device Registration & Listing · Hangzhou Zhejiang, CN · Registration 3011522054

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011522054
FEI Number
3011522054
Entity Name
Hangzhou Biotest Biotech Co.,Ltd.
City/State/Country
Hangzhou Zhejiang, CN
Establishment Address
17#,Futai Road,Zhongtai Street,Yuhang, Hangzhou Zhejiang 311121, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Hangzhou Biotest Biotech Co.,Ltd. (Owner Number: 10048622)
Owner / Operator Contact Address
17#,Futai Road,Zhongtai Street,Yuhang, Hangzhou, CN-ZJ 311121, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

COT Rapid Test Cassette (Urine) Advin Multi-Drug Screen Test ATTEST Drug Screen Dip Card ATTEST Drug Screen Cup OralTox Oral Fluid Drug Test

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PVD Test, Methamphetamine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3610 2024-07-17
PUX Test, Amphetamine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3100 2024-07-17
MKU Enzyme Immunoassay, Nicotine And Nicotine Metabolites Clinical Toxicology Class 1 862.3220 2022-04-26
PVJ Test, Cannabinoid, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3870 2025-03-13
PVH Test, Opiates, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3650 2024-07-17
PVE Test, Methadone, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3620 2025-03-13
NGE Test, Luteinizing Hormone (Lh), Over The Counter Clinical Chemistry Class 1 862.1485 2015-02-04
PVK Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3910 2025-03-13
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2022-04-24
PVG Test, Morphine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3640 2025-03-13
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2015-06-05
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2015-06-05
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2015-06-05
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2015-06-05
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2015-06-05
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2015-06-05
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2015-06-05
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2015-06-05
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2015-06-05
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2015-06-05
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2015-06-05
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2020-12-31
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2020-12-31
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2020-12-31
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2020-12-31
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2020-12-31
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2020-12-31
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2020-12-31
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2020-12-31
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2020-12-31
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2020-12-31
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2020-12-31
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2020-12-31
PUY Test, Barbiturate, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3150 2025-03-13
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2022-04-24
PUZ Test, Benzodiazepine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3170 2024-07-17
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2022-11-01
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2022-11-01
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2022-11-01
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2022-11-01
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2022-11-01
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2022-11-01
PVA Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3250 2024-07-17
QKP Coronavirus Antigen Detection Test System. Unknown Class N N/A 2022-02-24

Official Correspondent

WADE WU

US Agent Details

Daniel Hsu Business: Advin Biotech, Inc Email: daniel.hsu@advinbio.com Phone: (858) 8668382

Related Public Records

Same Entity

Hangzhou Biotest Biotech Co.,Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K964536 Teco Diagnostics ONE-STEP DIPSTICK PREGNANCY TEST 1997-02-11
K904016 Bhc Biotech , Ltd. MAXI TEST 1990-10-15
K870259 Leeco Diagnostics, Inc. VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044 1987-03-10
K820822 Hybritech, Inc. TANDEM HCG KIT 1982-04-29
K153050 Co-Innovation Biotech Co., Ltd. Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard 2016-04-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0043-2024 Universal Meditech Inc. 1
One Step Ovulation Test REF 200-01
Z-0006-05 Abbott Health Products, Inc. 2
AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Z-0006-2010 Biosite Inc 2
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0007-2010 Biosite Inc 2
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0008-2010 Biosite Inc 2
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011522054. Last updated year: 2026. Please use registration number 3011522054 when referencing this establishment in official correspondence.
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