FDA.reportPublic FDA data

CLUNGENE

Primary DI
06950921307594
Brand
CLUNGENE
Company
Hangzhou Clongene Biotech Co., Ltd.
Model
DDOA1h07-200802
Published
2026-03-26
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
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252118000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252118000CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy CupHangzhou Clongene Biotech Co., Ltd.2025-08-27NFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06950921307594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06950921307594069509213075946950921307594

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
724157438
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06950921308096CLUNGENEIRSVq008-2016122026-04-11
06950921300816CLUNGENEDSDOA1h07-2008052026-03-28
06950921307600CLUNGENEDSDOA1h07-2008062026-03-26
06950921307587CLUNGENEDDOA1h07-2008012026-03-24
06950921302070CLUNGENEDDOA1c07-2003072025-07-09
06950921302087CLUNGENEDDOA1c07-2003082025-07-09
06950921302179CLUNGENEDDOA1504-2003172025-07-09
06950921302186CLUNGENEDDOA1504-2003182025-07-09
06950921302223CLUNGENEWLH1001-2101322025-07-09
06950921302230CLUNGENEWLH1001-2101332025-07-09
06950921302377CLUNGENEStrip2023-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.NFV2026-07-20
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.NFW2026-07-20
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.NFY2026-07-20
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.NGL2026-07-20
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.NGM2026-07-20
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.PTG2026-07-20
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.PTH2026-07-20
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.NFT2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.PTG2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.PTH2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.NGM2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.NGL2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.NFY2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.NFW2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.NFV2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.NFT2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.NGG2026-07-20
G474M2105010mLife Rapid Drug TestMlife Diagnostics, LLCNFT2026-07-20
G474M2105010mLife Rapid Drug TestMlife Diagnostics, LLCNFY2026-07-20
G474M2105010mLife Rapid Drug TestMlife Diagnostics, LLCNGG2026-07-20
G474M2105010mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-07-20
G474M2105010mLife Rapid Drug TestMlife Diagnostics, LLCNFW2026-07-20
G474M2107010mLife Rapid Drug TestMlife Diagnostics, LLCNFW2026-07-20
G474M2107010mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-07-20
G474M2107010mLife Rapid Drug TestMlife Diagnostics, LLCNGG2026-07-20
G474M2107010mLife Rapid Drug TestMlife Diagnostics, LLCNFY2026-07-20
G474M2107010mLife Rapid Drug TestMlife Diagnostics, LLCNFT2026-07-20
G474M2113010mLife Rapid Drug TestMlife Diagnostics, LLCNFW2026-07-20
G474M2113010mLife Rapid Drug TestMlife Diagnostics, LLCNGG2026-07-20
G474M2113010mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-07-20