FDA.reportPublic FDA data

NOBLE

Primary DI
00850065976068
Brand
NOBLE
Company
Guangzhou Decheng Biotechnology Co., LTD
Model
NMCard-12-02-DK
Device description
NOBLE Multi-Drug Urine Test Dipcard, 12-Panel, 25T/Box
Published
2024-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
NFTTest, Amphetamine, Over The Counter
NFVTest, Benzodiazepine, 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
PTGTest, Methadone, Over The Counter
PTHTest, Barbiturate, Over The Counter
QAWTest, Tricyclic Antidepressants, Over The Counter
QBFTest, Propoxyphene, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFTTest, Amphetamine, Over The CounterClinical Toxicology2
NFVTest, Benzodiazepine, 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
PTGTest, Methadone, Over The CounterClinical Toxicology2
PTHTest, Barbiturate, Over The CounterClinical Toxicology2
QAWTest, Tricyclic Antidepressants, Over The CounterClinical Toxicology2
QBFTest, Propoxyphene, Over The CounterClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850065976068PrimaryGS10
30850065976069Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850065976068008500659760688500659760680850065976068
3085006597606930850065976069

GMDN Terms#

Term, Definition table
TermDefinition
Barbiturate 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 barbiturates 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
554534314
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974464591654One Step® LH Ovulation Rapid Test Dipstick (Urine)45T2026-07-15
06974464591678One Step® LH Ovulation Rapid Test Dipstick (Urine)40T2026-07-22
06974464591685One Step® LH Ovulation Rapid Test Dipstick (Urine)50T2026-07-22
06974464591272One Step® Progesterone (PdG) Urine Test Strip6T2026-03-31
06974464591296One Step® LH Ovulation Rapid Test Dipstick (Urine)20T2026-03-31
06974464591302One Step® LH Ovulation Rapid Test Dipstick (Urine)30T2026-03-31
06974464591319One Step® LH Ovulation Rapid Test Dipstick (Urine)60T2026-03-31
00850081966005Pregmate50T2026-07-08
06974464591333One Step® HCG Early Rapid Pregnancy Midstream Test5T2026-03-31
06974464591340One Step® HCG Early Rapid Pregnancy Strips15T2026-03-31
06974464591357One Step® 7-PANEL MULTI DRUG URINE TEST5T2026-03-31
00075450847635Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestIT415-3/V4072026-02-20
00075450847666Hy-Vee® Analog Pregnancy Rapid TestIT000416-2/V4072026-02-20
00075450847673Hy-Vee® Digital Pregnancy Rapid TestIT000417-2/V4072026-02-20
00075450847680Hy-Vee® Ovulation KitIT000418-11/V4072026-02-20
30075450847636Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestIT415-3/V4072026-02-20
00075450847642Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestIT415-2/V4072026-02-20
00075450847659Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestIT415-1/V4072026-02-20
30075450847667Hy-Vee® Analog Pregnancy Rapid TestIT000416-2/V4072026-02-20
30075450847674Hy-Vee® Digital Pregnancy Rapid TestIT000417-2/V4072026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10722066018979Rapid ResponseBTNX IncPTG2026-10-08
10722066018979Rapid ResponseBTNX IncNGM2026-10-08
10722066018979Rapid ResponseBTNX IncNGL2026-10-08
10722066018979Rapid ResponseBTNX IncQBF2026-10-08
10722066018979Rapid ResponseBTNX IncNGG2026-10-08
10722066018979Rapid ResponseBTNX IncNFY2026-10-08
10722066018979Rapid ResponseBTNX IncNFV2026-10-08
10722066018979Rapid ResponseBTNX IncNFW2026-10-08
10722066018979Rapid ResponseBTNX IncPTH2026-10-08
10722066018979Rapid ResponseBTNX IncQAW2026-10-08
10722066019013Rapid ResponseBTNX IncNGG2026-10-08
10722066019013Rapid ResponseBTNX IncPTH2026-10-08
10722066019013Rapid ResponseBTNX IncNFW2026-10-08
10722066019013Rapid ResponseBTNX IncNFV2026-10-08
10722066019013Rapid ResponseBTNX IncNFY2026-10-08
10722066019013Rapid ResponseBTNX IncQBF2026-10-08
10722066019013Rapid ResponseBTNX IncNGL2026-10-08
10722066019013Rapid ResponseBTNX IncNGM2026-10-08
10722066019013Rapid ResponseBTNX IncPTG2026-10-08
10722066019013Rapid ResponseBTNX IncQAW2026-10-08
10722066019020Rapid ResponseBTNX IncQAW2026-10-08
10722066019020Rapid ResponseBTNX IncPTG2026-10-08
10722066019020Rapid ResponseBTNX IncNGM2026-10-08
10722066019020Rapid ResponseBTNX IncNGL2026-10-08
10722066019020Rapid ResponseBTNX IncQBF2026-10-08
10722066019020Rapid ResponseBTNX IncNGG2026-10-08
10722066019020Rapid ResponseBTNX IncNFY2026-10-08
10722066019020Rapid ResponseBTNX IncNFV2026-10-08
10722066019020Rapid ResponseBTNX IncNFW2026-10-08
10722066019020Rapid ResponseBTNX IncPTH2026-10-08