FDA.reportPublic FDA data

Noble Drug Test Cup with AD (Urine)

Primary DI
10858886006855
Brand
Noble Drug Test Cup with AD (Urine)
Company
NOBLE MEDICAL INC
Model
NMCupC-10-104
Device description
6AM10/AMP500/COC150/FEN1/MDMA500/MET500/OPI300/OPI2000/OXY100/PCP25/THC50/(OX/pH/SG)/(GL/NI/CR)
Published
2026-07-09
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
NFWTest, Cannabinoid, Over The Counter
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
NGGTest, Methamphetamine, Over The Counter
NGLTest, Opiates, Over The Counter
NGMTest, Phencyclidine (Pcp), Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFTTest, Amphetamine, Over The CounterClinical Toxicology2
NFWTest, Cannabinoid, Over The CounterClinical Toxicology2
NFYTest, Cocaine And Cocaine Metabolites, Over The CounterClinical Toxicology2
NGGTest, Methamphetamine, Over The CounterClinical Toxicology2
NGLTest, Opiates, Over The CounterClinical Toxicology2
NGMTest, Phencyclidine (Pcp), Over The CounterUnknownU

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
10858886006855PrimaryGS10
00858886006858Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085888600685510858886006855
00858886006858008588860068588588860068580858886006858

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.

Regulatory Flags#

DUNS number
035967806
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
10858886006800Noble Drug Test Cup (Urine)NMCup-11-37-BT2023-05-19
10858886006824Noble Drug Test Cup with AD (Urine)NMCupC-12-75-BT2023-10-20
10858886006831Noble Drug Test Cup with AD (Urine)NMCupD-10-16-BT2023-11-02
10858886006848Noble Drug Test Cup (Urine)NMCup-12-012025-01-17
00858886006841Noble Drug Test Cup (Urine)NMCup-12-012025-01-17
00858886006834Noble Drug Test Cup with AD (Urine)NMCupD-10-16-BT2023-11-02
00858886006827Noble Drug Test Cup with AD (Urine)NMCupC-12-75-BT2023-10-20
00858886006803Noble Drug Test Cup (Urine)NMCup-11-37-BT2023-05-19
10858886006794Noble Drug Test Cup (Urine)E-NMCup-08-34-BT2023-05-11
00858886006797Noble Drug Test Cup (Urine)E-NMCup-08-34-BT2023-05-11
10858886006787Noble Drug Test Cup (Urine)E-NMCup-08-342023-05-05
00858886006780Noble Drug Test Cup (Urine)E-NMCup-08-342023-05-05
10858886006770Noble Drug Test Cup (Urine)NMCup-11-42-BT2023-02-14
00858886006773Noble Drug Test Cup (Urine)NMCup-11-42-BT2023-02-14
10858886006763Noble Dip Card with AD (Urine)E-NMCardA-09-37-BT2023-02-01
00858886006766Noble Dip Card with AD (Urine)E-NMCardA-09-37-BT2023-02-01
10858886006756Oraliss TM Oral Fluid Drug ScreenDMDI-G85-001n2022-10-28
00858886006759Oraliss TM Oral Fluid Drug ScreenDMDI-G85-001n2022-10-28
10858886006749Noble Drug Test Cup (Urine)NMCup-04-182022-10-19
00858886006742Noble Drug Test Cup (Urine)NMCup-04-182022-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810174471229Prime Screen®WONDFO USA CO., LTD.NFY2026-06-26
00810174471229Prime Screen®WONDFO USA CO., LTD.NFT2026-06-26
00810174471229Prime Screen®WONDFO USA CO., LTD.NGL2026-06-26
00810174471229Prime Screen®WONDFO USA CO., LTD.NFW2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NFW2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NGL2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NGG2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NFY2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NFT2026-06-26
10722066015053Rapid ResponseBTNX IncNGL2026-05-15
10722066015053Rapid ResponseBTNX IncNGG2026-05-15
10722066015053Rapid ResponseBTNX IncNGM2026-05-15
10722066015053Rapid ResponseBTNX IncNFW2026-05-15
10722066015053Rapid ResponseBTNX IncNFY2026-05-15
10722066015084Rapid ResponseBTNX IncNGM2026-05-15
10722066015084Rapid ResponseBTNX IncNFW2026-05-15
10722066015084Rapid ResponseBTNX IncNGL2026-05-15
10722066015084Rapid ResponseBTNX IncNFY2026-05-15
10722066015084Rapid ResponseBTNX IncNGG2026-05-15
10648564316280SnapCheckDx Rapid Urine THC TestHangzhou Aichek Medical Technology Co., Ltd.NFW2026-05-12
16936983131633Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983131633Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-16
10197344170203MEDLINEMEDLINE INDUSTRIES, INC.NFT2026-01-29
10197344170210MEDLINEMEDLINE INDUSTRIES, INC.NFT2026-01-23
10722066011260Rapid ResponseBTNX IncNGM2026-01-19
10722066011260Rapid ResponseBTNX IncNGL2026-01-19
10722066011260Rapid ResponseBTNX IncNFY2026-01-19
10722066011260Rapid ResponseBTNX IncNFW2026-01-19
10722066011260Rapid ResponseBTNX IncNGG2026-01-19
10722066011277Rapid ResponseBTNX IncNGM2026-01-19