Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004635103

FEI Number

3004635103

Entity Name

GUANGZHOU WONDFO BIOTECH CO., LTD.

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

No.8 Lizhishan Road, Science City, Huangpu District, Guangzhou Guangdong 510663, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GUANGZHOU WONDFO BIOTECH CO., LTD. (Owner Number: 9064561)

Owner / Operator Contact Address

No.8 lizhishan Road, Science City, Huangpu District, 510663, GUANGZHOU, CN-GD 510663, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Toptolife Strep A Test Wondfo Biotech Co. Ltd Preview Strep A Test Kit PRIME SCREEN® Marijuana (THC) Urine Test Strip SAFElife Cannabinoids (THC) Urine Test PRIME SCREEN® Cannabinoids (THC) Urine Test Strip WELLlife COVD-19 Antigen Test Hough COVID-19 Antigen Home Test WELLlife COVID-19 Antigen Home Test 2San COVID-19 Rapid Self-Test COLONOX FIT Aydmed Immunochemical Fecal Occult Blood (iFOB) Test EZCHECK® At-home iFOB Test Immunochemical Fecal Occult Blood Test(FIT) INDICAID iFOB IMMUNOCHEMICAL FECAL OCCULT BLOOD RAPID TEST RX Preview iFOB Immunochemical Fecal Occult Blood Test (FIT) WELLlife iFOB Immunochemical Fecal Occult Blood Test 2San Colorectal Health Test (immunochemical fecal occult blood test) INDICAID iFOB IMMUNOCHEMICAL FECAL OCCULT BLOOD RAPID TEST COLONOX FIT Immunochemical Fecal Occult Blood Test Test Yourself @ Home Immunochemical Fecal Occult Blood Test Toptolife iFOB Immunochemical Fecal Occult Blood Test Areta Multi-Drug Test Cup Micro Distributing II, Ltd, STAT Cup One Step Drug Test Prime Screen® Multi-Drug Urine Test Cup Easy@Home Multi-Drug Test Cup,ECDOA-1144A3 Clarity Multi-Drug Urine Test Cup (Urine) Easy@Home Drug Test Cup, ECDOA-1144A3 Areta Multi-Drug Test Cup, ACDOA-6125B SAFElife F-Cup Multi-Drug Urine Test Cup SAFElife T-Cup Multi-Drug Urine Test Cup Areta Multi-Drug Test Cup, ACDOA-754 Easy@Home Drug Test Cup, ECDOA-254 RST Home Drug Test Kit Cup (Urine) easy@Home® Drug Test Cup iSCREEN URINE TEST DRUG SCREEN SQUARE CUP 2SAN Home Drug Test Kit Medline Drug Test Cup Multi-Drug Test Cup IDT Multi Drug Urine Test Compact Cup iSCREEN URINE TEST DX DRUG SCREEN COMPACT ROUND CUP PRIME SCREEN® Multi-Drug Urine Test Cup iSCREEN URINE TEST DX DRUG SCREEN SQUARE CUP iSCREEN Urine Test Dx Drug Screen Round Cup SAFElife C-Cup Multi-Drug Urine Test Cup BluRapids® MULTI-DRUG TEST CUP iSCREEN URINE TEST DX DRUG SCREEN ROUND CUP iSCREEN Urine Test Drug Screen Square Cup easy@Home Drug Test Cup, ECDOA3-6125B Guangzhou Wondfo Biotech Co., Wondfo VacuLid Multi-Drug Urine Test Cup Areta Multi-Drug Test Cup, ACDOA-264 INDICAID Multi-Drug Urine Test Cup T-Cup Multi-Drug Urine Test Cup Areta Multi-Drug Test Cup, ACDOA-1144 Drug Test Cup QTEST Multi-Drug Urine Test Compact Cup Mintegrity® Multi-Drug Urine Test Cup T-Cup® Compact Multi-Drug Urine Test Cup Easy@Home Drug Test Cup, ECDOA-6125B IDT Multi Drug Urine Test Cup Easy@Home Drug Test Cup, ECDOA-7124 SAFElife S-Cup Multi-Drug Urine Test Cup UA Multi-Drug Urine Test Cup T-Cup® Multi-Drug Urine Test Cup CheckNow Multi - Drug Urine Test Cup iSCREEN Oral Fluid Test Drug Screen Swab SAFElife T-Swab Multi-Drug Oral Fluid Test SAFElife Multi-Panel Rapid Hair Test iSCREEN ORAL FLUID TEST DRUG SCREEN CUBE SAFElife T-Square Multi-Drug Oral Fluid Test Prime Screen® One Step Multi-Drug Oral Fluid Test iSCREEN ORAL FLUID TEST DRUG SCREEN SWAB STATSWAB® III Oral Fluid Drug Test TopazFIT Collection Kits Easy@Home Multi-Drug Urine Test Cup Easy@Home Multi-Drug Urine Test Panel Multi-Drug Urine Test Cup, Multi-Drug Urine Test Panel PRIME SCREEN® Single Panel Urine Test Cotinine (COT) SAFElife T-Dip Cotinine (COT) Urine Test Panel SAFElife T-Swab Cotinine (COT) Oral Fluid Test WELLlife COVID-19 Antigen Test Rx Control Kit QuickVue Influenza+SARS Test Control Kit WELLlife COVID-19 / Influenza A&B Antigen Test Control Kit WELLlife Influenza A&B Test Control Kit RST Home Drug Test Kit Cup (Urine) RST Home Drug Test Kit Panel (Urine) Easy@Home Single Drug Screen Test (Cannabinoids Urine Test), EDTH-114 Easy@Home Single Drug Screen Test (Cannabinoids Urine Test) MARIJUANA HOME DRUG TEST iSCREEN Oral Fluid Test Drug Screen Swab SAFElife T-Swab Multi-Drug Oral Fluid Test iSCREEN ORAL FLUID TEST DRUG SCREEN CUBE SAFElife T-Square Multi-Drug Oral Fluid Test iSCREEN ORAL FLUID TEST DRUG SCREEN SWAB STATSWAB® III Oral Fluid Drug Test Prime Screen® One Step Multi-Drug Oral Fluid Test Vacu Lid SAFElife T-Cup Drug Adulteration Urine Test Cup iSCREEN Oral Fluid Test Drug Screen Swab iSCREEN ORAL FLUID TEST DRUG SCREEN SWAB STATSWAB® III Oral Fluid Drug Test iSCREEN ORAL FLUID TEST DRUG SCREEN CUBE SAFElife Multi-Panel Rapid Hair Test Prime Screen® One Step Multi-Drug Oral Fluid Test SAFElife T-Swab Multi-Drug Oral Fluid Test SAFElife T-Square Multi-Drug Oral Fluid Test SAFElife T-Dip Fentanyl (FTY) Urine Test Panel SMC Direct Inc. RefuAH One Step HCG Urine Test (strip) CLARITY MIDSTREAM PREGNANCY TEST SMC Direct Inc. RefuAH One Step HCG Urine Test (cassette) One Step HCG Urine Test PREGNANCY TEST MEDLINE hCG Pregnancy Test Cassette (Urine) One Step HCG Urine Pregnancy Test dealmed HCG Pregnancy Test Cassette Pregnancy Test Strip Easy At Home Medical LLC Easy@Home Early Pregnancy Test (strip) INDICAID HCG PREGNANCY TEST STRIP Medline hCG Pregnancy Test Strip (Urine) Wondfo® Pregnancy Test Strip Wondfo® Fertility Combination Tests (Wondfo® Pregnancy Test Strip) Dealmed HCG Pregnancy Test Strip pregmate® Pregnancy Tests Clarity® MIDSTREAM PREGNANCY TEST HORMONElife Pregnancy Home Test Midstream HORMONElife Pregnancy Test Cassette Rx PREGABLE OVULATION & PREGNANCY TEST KIT (PREGABLE PREGNANCY TEST) UA One Step HCG Urine Test HORMONElife Fertility Combination Tests (HORMONElife Pregnancy Test Strip) HORMONElife Pregnancy Test Strip UA Fentanyl Urine Test (Cassette) SAFElife Fentanyl Urine Home Test (Dip Card) SAFElife Fentanyl Urine Test (Cassette) SAFElife Fentanyl Urine Home Test (Cassette) UA Fentanyl Urine Test (Dip Card) SAFElife Fentanyl Urine Test (Dip Card) SAFElife T-Dip Methamphetamine (MET/mAMP) Urine Test Panel SAFElife T-Dip Multi-Drug Urine Test Panel Easy@Home® Multi-Drug Screen Test, EDOAP-754 SAFElife T-Dip Methadone (MTD) Urine Test Panel Rx Easy@Home® Multi-Drug Screen Test, EDOAP-144 SAFElife T-Dip Oxycodone (OXY) Urine Test Panel Rx SAFElife T-Dip Methamphetamine (MET/mAMP) Urine Test Panel Rx SAFElife T-Dip Phencyclidine (PCP) Urine Test Panel Rx SAFElife T-Dip Methamphetamine (MET500/mAMP500) Urine Test Panel Rx ONCORE DETOX Single Drug Dip Card (COC) Easy@Home® Multi-Drug Screen Test, EDOAP-254 SAFElife T-Dip Single Drug Urine Test Panel SAFElife T-Dip Methylenedioxymethamphetamine (MDMA) Urine Test Panel Rx SAFElife T-Dip Amphetamine (AMP) Urine Test Panel Rx Single Drug Urine Test Panel PRIME SCREEN® Multi-Panel Urine Test SAFElife T-Dip Cannabinoids (THC) Urine Test Panel Rx ONCORE DETOX Single Drug Dip Card (OPI) Multi-Drug Screen Test PRIME SCREEN® Single Panel Urine Test Cocaine (COC) Multi-Drug Urine Test Panel SAFElife T-Dip Cannabinoids (THC) Urine Test Panel SAFElife T-Dip Oxazepam (BZO) Urine Test Panel Rx SAFElife T-Dip Morphine (OPI) Urine Test Panel Rx SAFElife T-Dip Phencyclidine (PCP) Urine Test Panel SAFElife T-Dip Secobarbital (BAR) Urine Test Panel Rx Easy Healthcare Corporation, Easy@Home Multi-Drug Screen Test Easy@Home Multi-Drug Screen Test, EDOAP-7125 SAFElife T-Dip Multi-Drug Urine Test Panel Rx SAFElife T-Dip Amphetamine (AMP) Urine Test Panel SAFElife T-Dip Morphine (MOP) Urine Test Panel SAFElife T-Dip Buprenorphine (BUP) Urine Test Panel Rx Easy@Home® Multi-Drug Screen Test, EDOAP-065 SAFElife T-Dip Methylenedioxymethamphetamine (MDMA) Urine Test Panel SAFElife T-Dip Cocaine (COC150) Urine Test Panel Rx SAFElife T-Dip Methadone (MTD) Urine Test Panel SAFElife T-Dip Amphetamine (AMP500) Urine Test Panel SAFElife T-Dip Nortriptyline (TCA) Urine Test Panel ONCORE DETOX Single Drug Dip Card (THC) SAFElife T-Dip Propoxyphene (PPX) Urine Test Panel Prime Screen® Multi-Panel Urine Test Mintegrity® Single-Panel Urine Test (Cannabinoids (THC)) Easy@Home® Multi-Drug Screen Test, EDOAP-7104 SAFElife T-Dip Oxycodone (OXY) Urine Test Panel SAFElife T-Dip Oxazepam (BZO) Urine Test Panel SAFElife T-Dip Nortriptyline (TCA) Urine Test Panel Rx Mintegrity® Multi-Panel Urine Test SAFElife T-Dip Cocaine (COC) Urine Test Panel Rx iSCREEN URINE TEST DX DRUG SCREEN DIP CARD SAFElife T-Dip Secobarbital (BAR) Urine Test Panel Easy@Home® Multi-Drug Screen Test, EDOAP-3104 PRIME SCREEN® Single Panel Urine Test Oxazepam (BZO) Easy@Home® Multi-Drug Screen Test, EDOAP-1124 PRIME SCREEN® Single Panel Urine Test Cannabinoids (THC) SAFElife T-Dip Morphine (OPI) Urine Test Panel Easy@Home® Multi-Drug Screen Test, EDOAP-654 Easy@Home® Multi-Drug Screen Test, EDOAP-6125B SAFElife T-Dip Amphetamine (AMP500) Urine Test Panel Rx SAFElife T-Dip Morphine (MOP) Urine Test Panel Rx ONCORE DETOX Single Drug Dip Card (AMP) Single Drug Screen Test ONCORE DETOX Multi-Drug Dip Card Easy@Home® Multi-Drug Screen Test, EDOAP-264 SAFElife T-Dip Cocaine (COC150) Urine Test Panel Easy@Home® Single Drug Screen Test SAFElife T-Dip Buprenorphine (BUP) Urine Test Panel SAFElife T-Dip Cocaine (COC) Urine Test Panel SAFElife T-Dip Methamphetamine (MET500/mAMP500) Urine Test Panel SAFElife T-Dip Propoxyphene (PPX) Urine Test Panel Rx Easy@Home Multi-Drug Screen Test, EDOAP-4104 ONCORE DETOX Single Drug Dip Card (MET/mAMP) SAFElife Multi-Panel Rapid Hair Test One Step Saliva Alcohol Test Strip PRIME SCREEN® Saliva Alcohol Test Strip Toptolife hCG Urine/Serum Combo Pregnancy Test One Step HCG Urine/Serum Test Independent Medical Co-op Inc., IMCO HCG Combo Cassettes HORMONElife Fertility Combination Tests (HORMONElife Ovulation Test Strip) Ovulation Tests Easy@Home Ovulation Test Kit (Strip) Wondfo® Ultra Accurate Ovulation Test Strip One Step Ovulation Test Modern Fertility Ovulation Predictor Test Easy@Home Ovulation Test (Midstream) Wondfo® Fertility Combination Tests (Wondfo® Ovulation Test Strip) Ovulation Test Strip pregmate® OVULATION TESTS Modern Fertility Ovulation Test INDICAID OVULATION TEST STRIP Wondfo® Ovulation Test Strip Premom Ovulation Test, PMS2-S Ovulation Test (Quantitative Ovulation Predictor) HORMONElife Ultra Accurate Ovulation Test Strip Mintegrity® Ovulation Test OVULATION TEST Ovulation Test PREGABLE OVULATION & PREGNANCY TEST KIT (PREGABLE OVULATION TEST) HORMONElife Ovulation Test Strip Ovarian Reserve Screening Test HORMONElife Ultra Accurate FSH Test Strip HORMONElife PdG Urine Test Strip Wondfo® PdG Urine Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2014-05-22
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2011-10-27
QYT	Over-The-Counter Covid-19 Antigen Test	Microbiology	Class 2	866.3984	2024-10-22
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2017-07-11
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2018-12-17
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2018-12-17
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2018-12-17
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2018-12-17
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2018-12-17
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2018-12-17
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2018-12-17
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2018-12-17
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2018-12-17
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2018-12-17
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2018-12-17
PUX	Test, Amphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3100	2018-01-08
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2024-06-17
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2013-08-06
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2013-08-06
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2013-08-06
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2013-08-06
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2013-08-06
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2013-08-06
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2013-08-06
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2013-08-06
MRS	Test System, Nicotine, Cotinine, Metabolites	Clinical Toxicology	Class 1	862.3220	2019-06-26
MJZ	Kit, Direct Antigen, Positive Control	Clinical Chemistry	Class 1	862.1660	2025-09-09
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2012-10-18
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2012-10-18
PVJ	Test, Cannabinoid, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3870	2018-01-08
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2016-08-28
PVH	Test, Opiates, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3650	2018-01-08
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2008-01-01
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2008-01-01
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2024-08-20
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2020-10-30
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2020-10-30
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2020-10-30
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2020-10-30
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2020-10-30
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2020-10-30
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2020-10-30
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2020-10-30
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2020-10-30
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2020-10-30
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2020-10-30
PUZ	Test, Benzodiazepine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3170	2018-01-18
DIC	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method	Clinical Toxicology	Class 2	862.3040	2016-09-18
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2009-08-27
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2016-09-11
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2023-12-06
QKE	Immunoassay, Pregnanediol Glucuronide, Over The Counter	Clinical Chemistry	Class 1	862.1620	2023-12-19

Official Correspondent

Jihua Wang

US Agent Details

Joe Shia Business: LSI International Inc. Email: shiajl@yahoo.com Phone: (240) 5057880

Related Public Records

Same Entity

GUANGZHOU WONDFO BIOTECH CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3023322455	GUANGZHOU WONDFO BIOTECH CO., LTD.	Guangzhou Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K133343	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO RAPID STREP A TEST	2014-01-31
K110182	Guangzhou Wondfo Biotech Co., Ltd.	CANNABINOIDS URINE TEST	2011-05-20
K121557	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST	2012-07-25
K920418	Instrumentation Laboratory CO	IL TEST CANNABINOID, 35282	1992-02-27
K241317	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)	2024-09-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-2787-2018	Guangzhou Wondfo Biotech Co., Ltd.	2	TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
Z-2788-2018	Guangzhou Wondfo Biotech Co., Ltd.	2	TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO, MTD30,OPl40,OXY20, THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
Z-2789-2018	Guangzhou Wondfo Biotech Co., Ltd.	2	TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004635103. Last updated year: 2026. Please use registration number 3004635103 when referencing this establishment in official correspondence.