FDA.reportPublic FDA data

Multi-Drug Screen Test

Primary DI
B115VABCUP08650
Brand
Multi-Drug Screen Test
Company
ADVIN BIOTECH, INC.
Model
VABCup-08-65
Published
2025-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NFTTest, Amphetamine, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFTTest, Amphetamine, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252867000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252867000VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test CupAdvin Biotech, Inc.2025-10-09NFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B115VABCUP08651PrimaryHIBCC0
B115VABCUP08650Unit of UseHIBCC0

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
B115ABCUP09351Advin Multi-Drug Screen TestABCup-09-35ABCup-09-352020-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16936983131633Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983131640Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983131657Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983131664Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983131671Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983131695Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983138632Multi-Drug 12 Drugs Rapid Test Cup Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983141120Discover Multi-Drug 12 Drugs Rapid Test Cup Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983141137Discover Multi-Drug 12 Drugs Rapid Test Cup Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983144688Discover Multi-Drug 10 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983144770Discover Multi-Drug 9 Drugs Rapid Test Cup (Urine) Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983148846Discover Multi-Drug 12 Drugs Rapid Test Cup (Urine) Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983153819Discover Multi-Drug 13 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-15
16936983165379Discover Multi-Drug 5 Drugs Rapid Test Cup(Urine) Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-15
16936983169599Alltest Multi-Drug Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFT2026-04-15
16936983169605Alltest Multi-Drug Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFT2026-04-15
16936983169865Discover Multi-Drug 6 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-15
16936983169872Discover Multi-Drug 8 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-15
16936983170007Alltest Multi-Drug 12 Drugs Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFT2026-04-15
16936983170014Alltest Multi-Drug 13 Drugs Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFT2026-04-15
16936983170021Alltest Multi-Drug 14 Drugs Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFT2026-04-15
16936983170038Alltest Multi-Drug 14 Drugs Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFT2026-04-15
16936983171998Alltest Multi-Drug 13 Drugs Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFT2026-04-15
16936983172025Alltest Multi-Drug 13 Drugs Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFT2026-04-15
16936983172414Alltest Multi-Drug 13 Drugs Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFT2026-04-14
16936983172421Alltest Multi-Drug 12 Drugs Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFT2026-04-14
16936983179642Alltest Multi-Drug 13 Drugs Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFT2026-04-14
16936983179963Multi-Drug 12 Drugs Rapid Test Cup (Urine) Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-14
16936983180600Alltest Multi-Drug 13 Drugs Test CupHangzhou AllTest Biotech Co., Ltd.NFT2026-04-14
16936983180617Alltest Multi-Drug 14 Drugs Test CupHangzhou AllTest Biotech Co., Ltd.NFT2026-04-14