FDA.reportPublic FDA data

Noble Drug Test Cup (Urine)

Primary DI
00858886006797
Brand
Noble Drug Test Cup (Urine)
Company
NOBLE MEDICAL INC
Model
E-NMCup-08-34-BT
Device description
6AM10/AMP500/COC150/MDMA500/MET500/OPI300/OXY100/PCP25
Published
2023-05-11
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
PVHTest, Opiates, Employment And Insurance Testing, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PVHTest, Opiates, Employment And Insurance Testing, ExemptClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182123000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182123000ATTEST Drug Screen Cup, ATTEST Drug Screen Dip CardAdvin Biotech, Inc.2019-03-29DJG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858886006794PrimaryGS10
00858886006797Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085888600679410858886006794
00858886006797008588860067978588860067970858886006797

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
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
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
01085888600657Noble Dip Card (Urine)NMCard-12-02-BT2022-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVH2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVH2026-04-29
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPVH2026-04-03
B29880913EI0DrugCheck Express Diagnostic Int'l, Inc.PVH2026-02-23
B29880502EI0DrugCheck Express Diagnostic Int'l, Inc.PVH2026-02-20
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVH2026-01-29
00810174470963PRIME SCREEN®WONDFO USA CO., LTD.PVH2025-12-05
00810174471007PRIME SCREEN®WONDFO USA CO., LTD.PVH2025-12-05
00810174471182SAFElife™WONDFO USA CO., LTD.PVH2025-12-05
00810174471212PRIME SCREEN®WONDFO USA CO., LTD.PVH2025-12-05
00810174471144PRIME SCREEN®WONDFO USA CO., LTD.PVH2025-12-03
00810174471168PRIME SCREEN®WONDFO USA CO., LTD.PVH2025-12-03
G474M3209010VerifyMlife Diagnostics, LLCPVH2025-09-05
G474M3208010VerifyMlife Diagnostics, LLCPVH2025-07-21
00816862026634Prime ScreenWONDFO USA CO., LTD.PVH2025-07-03
G474M3106010ClassicMlife Diagnostics, LLCPVH2025-06-20
G474M3105010ClassicMlife Diagnostics, LLCPVH2025-06-19
00816862026337SAFElife™WONDFO USA CO., LTD.PVH2025-05-19
G474MC002080001EI0ClassicMlife Diagnostics, LLCPVH2025-03-19
06977469280219S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold)Eterbio, Inc.PVH2024-12-18
G474MC001050002EI0ClassicMlife Diagnostics, LLCPVH2024-11-05
G474MV002110001EI0VerifyMlife Diagnostics, LLCPVH2024-10-08
00850054867704AmazewellGuangzhou Decheng Biotechnology Co., LTDPVH2024-09-30
00850054867711AmazewellGuangzhou Decheng Biotechnology Co., LTDPVH2024-09-30
00850054867728AmazewellGuangzhou Decheng Biotechnology Co., LTDPVH2024-09-30
00850054867735AmazewellGuangzhou Decheng Biotechnology Co., LTDPVH2024-09-30
00850054867896AmazewellGuangzhou Decheng Biotechnology Co., LTDPVH2024-09-29
00850054867964AmazewellGuangzhou Decheng Biotechnology Co., LTDPVH2024-09-29
00850054867773AmazewellGuangzhou Decheng Biotechnology Co., LTDPVH2024-09-29
00850054867797AmazewellGuangzhou Decheng Biotechnology Co., LTDPVH2024-09-29