FDA.reportPublic FDA data

NOBLE

Primary DI
10858886006480
Brand
NOBLE
Company
NOBLE MEDICAL INC
Model
NM-DJA-147-341
Catalog number
DJA-147-341
Device description
Drugs of Abuse Test Cup for COC300/0PI2000/AMP1000/PCP25 + (OX/PCC/Ph/S.G.)
Published
2020-04-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DJGEnzyme Immunoassay, Opiates
DKZEnzyme Immunoassay, Amphetamine
LAFGas Chromatography, Methamphetamine
LCMEnzyme Immunoassay, Phencyclidine
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
LAFGas Chromatography, MethamphetamineClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858886006480PrimaryGS10
00858886006483Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085888600648010858886006480
00858886006483008588860064838588860064830858886006483

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
Lot or batch
true
Expiration date on label
true

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
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LAF2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LAF2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONLCM2020-05-29
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2020-05-29
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2020-05-29
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2020-05-29
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2019-02-12
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2019-02-12
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2019-02-12
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2018-03-30
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONLCM2018-03-30
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2018-03-30
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2018-03-30
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.LDJ2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DJG2017-11-15