FDA.reportPublic FDA data

Noble Drug Test Cup with AD (Urine)

Primary DI
00858886006827
Brand
Noble Drug Test Cup with AD (Urine)
Company
NOBLE MEDICAL INC
Model
NMCupC-12-75-BT
Device description
AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/TCA1000(pH/OX/SG)/(GL/NI/CR)
Published
2023-10-20
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
LCMEnzyme Immunoassay, Phencyclidine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCMEnzyme Immunoassay, PhencyclidineUnknownU

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
10858886006824PrimaryGS10
00858886006827Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085888600682410858886006824
00858886006827008588860068278588860068270858886006827

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656726HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyLCM2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONLCM2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONLCM2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONLCM2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONLCM2020-05-29
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2019-09-28
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONLCM2019-02-13
10694644300755RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-07-05
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2018-05-23
10694644300731RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-05-23
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2018-04-19
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-04-19