ADVIN BIOTECH, INC.

FDA Device Registration & Listing · San Diego, CA, US · Registration 3010934853

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
3010934853
FEI Number
3010934853
Entity Name
ADVIN BIOTECH, INC.
City/State/Country
San Diego, CA, US
Establishment Address
10140 Mesa Rim Rd., Unit 1, San Diego, CA 92121, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Advin Biotech Inc (Owner Number: 10046939)
Owner / Operator Contact Address
10140 Mesa Rim Rd., Unit 1, San Diego, CA 92121, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

OralTox Oral Fluid Drug Test KNOW DRUG TEST CUP Advin Multi Drug Screen Test ATTEST DRUG TEST OralTox Oral Fluid Drug Test COVID-19 IgG/IgM (-) Control COVID-19 IgG/IgM (+) Control Advin COVID-19 Antigen Test @Home OralTox Oral Fluid Drug Test QuikTox Ultra Cup Rapid Drug Test Multi-Drug Screen Test Cup MYM Multi-Drug Urine Test Cup Topaz Multi Screen Test Cup RED TUNICA DOPI™ Multi-Drug Detection System Premier Bio-Cup Rapid Test CheckTox Multi-Drug Test Cup DrugExam Multi Drug Screen Test Cup INSTA-SCREEN-2® Test Cup Identify® Health Drug Screen Test Cup VistaFlow Test Cup Identify Diagnostics Drug Test Identify® Diagnostics USA Drug Test Noble Drug Test Cup QuikTox @Home Ultra Cup CLIAWaived Inc. Instant Drug Test Cup Plus Bicycle Health CLIA Waived Drug Test Cup CLIAWaived Inc. Multi-Drug Screen Test Cup Plus Premier Bio-Cup & Bio-Dip ATTEST Drug Screen Cup & DIP Card Multi-Drug Screen Test KNOW DRUG CUP SmartScreen cup Premier BIO CUP & BIO DIP ATTEST RightSign Delta-9 THC Saliva Tracer Test ATTEST Drug Test KNOW Drug Test Cup SmartScreen Cup Advin Multi Drug Screen Test Premier Bio Cup & Bio Dip SmartScreen cup KNOW Drug Test Cup ATTEST Drug Test Advin Multi Drug Screen Test Premier BIO CUP & BIO DIP OralTox Oral Fluid Drug Test KNOW Drug Test Cup ATTEST Drug Test Premier Bio Cup & Bio Dip Advin Multi Drug Screen Test SmartScreen Cup Advin Multi Drug Screen Test Premier Bio Cup & Bio Dip KNOW DRUG TEST CUP SmartScreen Cup ATTEST Drug Screen Cup & DIP Card Premier Bio-Cup & Bio-Dip Multi-Drug Screen Test Identify Diagnostics USA Drug Screen Test (MET) Identify Health Drug Screen Test (AMP) Identify Diagnostics USA Drug Screen Test (OPI300) Identify Diagnostics Drug Test CheckTox Multi-Drug Test Bicycle Health CLIA WAIVED DRUG TEST (MTD) Identify Health Drug Screen Test (TCA) Bicycle Health CLIA WAIVED DRUG TEST (BUP) ATTEST Identify Diagnostics USA Drug Screen Test (OXY) Versea Easy Lab 6 Drugs Home Testing Kit Premier UTox Cup QuikTox Ultra Cup & Ultra Dip DrugExam Multi Drug Screen Test Identify Health Drug Screen Test (BUP) Identify Diagnostics USA Drug Screen Test (BAR) Bicycle Health CLIA WAIVED DRUG TEST (OPI2000) Rapid Response™ Multi-Drug One Step Cup (Urine) Bicycle Health CLIA WAIVED DRUG TEST (BAR) Identify Health Drug Screen Test (PPX) Identify Diagnostics USA Drug Screen Test (TCA) Advin Multi-Drug Screen Test Cassette/Cup/Dip Card Identify Health Drug Screen Test (OPI300) NexScreen Drug Screen Cup Identify Diagnostics USA Drug Screen Test (MTD) Identify Health Drug Screen Test (BZO) Identify Diagnostics USA Drug Screen Test (MDMA) VistaFlow test yourself @home Instant Drug Test Cup INSTA-SCREEN-2 Cup Bicycle Health CLIA WAIVED DRUG TEST (BZO) Bicycle Health CLIA WAIVED DRUG TEST (PPX) Identify Diagnostics USA Drug Screen Test (AMP) Identify Diagnostics USA Drug Screen Test (COC) Bicycle Health CLIA WAIVED DRUG TEST (THC) RightSign Drug Screen Test Identify Health Drug Screen Test (OXY) Identify Diagnostics USA Drug Screen Test (PPX) Identify Health Drug Screen Test (MET) Identify Health Drug Screen Test (MTD) Identify Diagnostics USA Drug Screen Test (BZO) Bicycle Health CLIA WAIVED DRUG TEST (PCP) Bicycle Health CLIA WAIVED DRUG TEST (OXY) Bicycle Health CLIA WAIVED DRUG TEST (COC) Identify Health Drug Screen Test (THC) Identify Health Drug Screen Test (EDDP) Bicycle Health CLIA WAIVED DRUG TEST (MDMA) Instant Drug Test Cup/Card II (IDTC II) Boulder Care Multi-Drug Test Cup QuikTox Ultra Cup Identify Diagnostics USA Drug Screen Test (OPI2000) Identify Diagnostics USA Drug Screen Test (EDDP) Identify Health Drug Screen Test (COC) Sienna Multi-Drug Test (Cup and Dip Card) Bicycle Health CLIA WAIVED DRUG TEST(OPI300) Identify Diagnostics USA Drug Screen Test (THC) Identify Health Drug Screen Test (PCP) Premier Bio-Cup & Bio-Dip Bicycle Health CLIA WAIVED DRUG TEST (MET) Identify Health Drug Screen Test (OPI2000) Identify Diagnostics USA Drug Screen Test (PCP) Bicycle Health CLIA WAIVED DRUG TEST (EDDP) Multi-Drug Screen Test Cup Bicycle Health CLIA WAIVED DRUG TEST (AMP) Identify Diagnostics USA Drug Screen Test (BUP) Noble Dip Card/Drug Test Cup Precision Plus Multi Panel Urine Drug Test Cup Bicycle Health CLIA WAIVED DRUG TEST (TCA) Identify Health Drug Screen Test (BAR) Utest Drug Test Identify Health Drug Screen Test (MDMA) CoronaCheck COVID-19 IgG/IgM Rapid Test Cassette RightSign COVID-19 IgG/IgM Rapid Test Cassette Premier Biotech COVID-19 IgG/IgM Rapid Test Cassette Advin Multi Drug Screen Test KNOW Drug Test Cup SmartScreen Cup ATTEST Drug Test Premier Bio Cup & Bio Dip

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2022-05-26
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2022-05-26
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2022-05-26
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2022-05-26
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2022-05-26
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2022-05-26
PVA Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3250 2017-10-30
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2022-05-26
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2022-05-26
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2022-05-26
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2022-05-26
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2022-05-26
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2022-05-26
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2022-05-26
OHQ Multi-Analyte Controls Unassayed Clinical Chemistry Class 1 862.1660 2020-08-12
QKP Coronavirus Antigen Detection Test System. Unknown Class N N/A 2023-01-09
PUZ Test, Benzodiazepine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3170 2025-08-27
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2025-11-25
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2025-11-25
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2025-11-25
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2025-11-25
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2025-11-25
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2025-11-25
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2025-11-25
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2025-11-25
QBF Test, Propoxyphene, Over The Counter Clinical Toxicology Class 2 862.3700 2025-11-25
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2025-11-25
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2025-11-25
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2020-12-29
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2020-12-29
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2020-12-29
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2020-12-29
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2020-12-29
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2020-12-29
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2020-12-29
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2020-12-29
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2020-12-29
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2020-12-29
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2020-12-29
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2020-12-29
PVJ Test, Cannabinoid, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3870 2018-01-11
PVD Test, Methamphetamine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3610 2017-10-31
PVI Test, Propoxyphene, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3700 2017-10-31
MKU Enzyme Immunoassay, Nicotine And Nicotine Metabolites Clinical Toxicology Class 1 862.3220 2025-08-27
PVH Test, Opiates, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3650 2017-10-31
PUX Test, Amphetamine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3100 2017-10-25
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2019-04-03
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2019-04-03
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2019-04-03
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2019-04-03
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2014-06-03
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2014-06-03
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2014-06-03
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2014-06-03
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2014-06-03
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2014-06-03
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2014-06-03
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2014-06-03
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2014-06-03
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2014-06-03
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2014-06-03
QKO Reagent, Coronavirus Serological Unknown Class N N/A 2020-06-16
PVG Test, Morphine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3640 2017-10-31

Official Correspondent

Yedda Huang

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Advin Biotech Inc
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
K153050 Co-Innovation Biotech Co., Ltd. Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard 2016-04-26
K151478 Guangzhou Wondfo Biotech Co., Ltd. Wondfo CR3 Keyless Split Sample Cup 2015-07-01
K150179 Guangzhou Wondfo Biotech Co., Ltd. CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids 2015-02-25
K112310 Guangzhou Wondfo Biotech Co., Ltd. WONDFO METHADONE URINE TEST,OPIATE TEST 2011-09-08
K093175 Guangzhou Wondfo Biotech Co., Ltd. WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES 2010-08-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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
Z-0009-2010 Biosite Inc 2
Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0010-2010 Biosite Inc 2
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. 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 3010934853. Last updated year: 2026. Please use registration number 3010934853 when referencing this establishment in official correspondence.
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