FDA.reportPublic FDA data

Precision Plus Multi Panel Urine Drug Test Cup

Primary DI
00840050517536
Brand
Precision Plus Multi Panel Urine Drug Test Cup
Company
ADVIN BIOTECH, INC.
Model
PPCup-14-01
Device description
AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/TCA1000/THC50
Published
2024-05-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DISEnzyme Immunoassay, Barbiturate
DJCThin Layer Chromatography, Methamphetamine
DJGEnzyme Immunoassay, Opiates
DJREnzyme Immunoassay, Methadone
DKZEnzyme Immunoassay, Amphetamine
JXMEnzyme Immunoassay, Benzodiazepine
LCMEnzyme Immunoassay, Phencyclidine
LDJEnzyme Immunoassay, Cannabinoids
LFGRadioimmunoassay, Tricyclic Antidepressant Drugs
NGGTest, Methamphetamine, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DJREnzyme Immunoassay, MethadoneClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2
LFGRadioimmunoassay, Tricyclic Antidepressant DrugsClinical Toxicology2
NGGTest, Methamphetamine, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122809000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122809000Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech2013-06-17DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840050517536PrimaryGS10
10840050517533Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840050517536008400505175368400505175360840050517536
1084005051753310840050517533

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006463333
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B115PABCUP12161Multi-Drug Screen Test P-ABCup-12-162026-05-01
B115ABCASS1CANAO25T1Advin COVID-19 Antigen Test @HomeABCASS(1)-CAN-AO-25T2025-12-29
B115VABCUP08661Multi-Drug Screen TestVABCup-08-662025-12-10
B115VABCUP08660Multi-Drug Screen TestVABCup-08-662025-12-10
B115VABCUP13721Multi-Drug Screen TestVABCup-13-722025-12-10
B115VABCUP15141Multi-Drug Screen TestVABCup-15-142025-12-10
B115VABCUP08651Multi-Drug Screen Test VABCup-08-652025-12-08
B115VABCUP08650Multi-Drug Screen Test VABCup-08-652025-12-08
B115ABCARD01MET5001Advin Multi-Drug Screen TestABCard-01-MET500ABCard-01-MET5002021-05-06
B115ABCARD05511Advin Multi-Drug Screen TestABCard-05-51ABCard-05-512020-08-26
B115ABCARD07461Advin Multi-Drug Screen TestABCard-07-46ABCard-07-462020-06-25
B115ABCARD09351Advin Multi-Drug Screen TestABCard-09-35ABCard-09-352020-06-25
B115ABCARD11371Advin Multi-Drug Screen Test 1ABCard-11-372021-12-17
B115ABCARD12711Advin Multi-Drug Screen TestABCard-12-71ABCard-12-712020-11-09
B115ABCARDA11391Advin Multi-Drug Screen Test with SVTABCardA-11-39ABCardA-11-392020-06-24
B115ABCARDC07431Advin Multi-Drug Screen Test with SVTABCardC-07-43ABCardC-07-432021-02-15
B115ABCARDC12441Advin Multi-Drug Screen Test with SVTABCardC-12-44ABCardC-12-442020-06-25
B115ABCARDC12711Advin Multi-Drug Screen Test with SVTABCardC-12-71ABCardC-12-712020-06-25
B115ABCUP05511Advin Multi-Drug Screen TestABCup-05-51ABCup-05-512020-08-26
B115ABCUP07461Advin Multi-Drug Screen TestABCup-07-46ABCup-07-462020-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817405024247iScreen™Instant Technologies, Inc.DIO2026-08-01
00817405024247iScreen™Instant Technologies, Inc.DIS2026-08-01
00817405024247iScreen™Instant Technologies, Inc.DJG2026-08-01
00817405024247iScreen™Instant Technologies, Inc.JXM2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LCM2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LDJ2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LFG2026-08-01
00810173656719HealgenHealgen Scientific Limited Liability CompanyLDJ2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyLCM2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDJR2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyLFG2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyJXM2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDJG2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDIO2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDKZ2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDIS2026-07-31
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500217OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500224OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500231OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500248OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500255OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500262OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500279OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500286OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500293OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500309OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11