FDA.reportPublic FDA data

Multi-Drug Screen Test

Primary DI
B115VABCUP08660
Brand
Multi-Drug Screen Test
Company
ADVIN BIOTECH, INC.
Model
VABCup-08-66
Published
2025-12-10
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
B115VABCUP08661PrimaryHIBCC0
B115VABCUP08660Unit 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
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
B115ABCUP09351Advin Multi-Drug Screen TestABCup-09-35ABCup-09-352020-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500217OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500224OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500231OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500248OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500255OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500262OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500279OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500286OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500293OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500309OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500316OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500323OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500330OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500347OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500354OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500361OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500378OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500385OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500392OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500408OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500415OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500422OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500439OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500446OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500453OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500460OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11