FDA.reportPublic FDA data

CLUNGENE

Primary DI
06950921302087
Brand
CLUNGENE
Company
Hangzhou Clongene Biotech Co., Ltd.
Model
DDOA1c07-200308
Published
2025-07-09
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
NGGTest, Methamphetamine, Over The Counter
NGLTest, Opiates, Over The Counter
NGMTest, Phencyclidine (Pcp), Over The Counter
QAWTest, Tricyclic Antidepressants, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGGTest, Methamphetamine, Over The CounterClinical Toxicology2
NGLTest, Opiates, Over The CounterClinical Toxicology2
NGMTest, Phencyclidine (Pcp), Over The CounterUnknownU
QAWTest, Tricyclic Antidepressants, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181790000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181790000CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupHangzhou Clongene Biotech Co., Ltd.2018-07-26NGL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06950921302087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06950921302087069509213020876950921302087

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
724157438
Device count
1
Lot or batch
true
Manufacturing date on label
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
06950921307594CLUNGENEDDOA1h07-2008022026-03-26
06950921307600CLUNGENEDSDOA1h07-2008062026-03-26
06950921307587CLUNGENEDDOA1h07-2008012026-03-24
06950921302070CLUNGENEDDOA1c07-2003072025-07-09
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.NGM2026-07-20
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.NGL2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.NGG2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.NGL2026-07-20
00850076289713HYSEN Multiple Drugs Test CupHYSEN INC.NGM2026-07-20
G474M2105010mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-07-20
G474M2105010mLife Rapid Drug TestMlife Diagnostics, LLCNGG2026-07-20
G474M2107010mLife Rapid Drug TestMlife Diagnostics, LLCNGG2026-07-20
G474M2107010mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-07-20
G474M2113010mLife Rapid Drug TestMlife Diagnostics, LLCNGG2026-07-20
G474M2113010mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-07-20
G474M2116010mLife Rapid Drug TestMlife Diagnostics, LLCQAW2026-07-20
G474M2116010mLife Rapid Drug TestMlife Diagnostics, LLCNGM2026-07-20
G474M2116010mLife Rapid Drug TestMlife Diagnostics, LLCNGG2026-07-20
G474M2116010mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-07-20
G474M2117010mLife Rapid Drug TestMlife Diagnostics, LLCNGG2026-07-20
G474M2117010mLife Rapid Drug TestMlife Diagnostics, LLCQAW2026-07-20
G474M2117010mLife Rapid Drug TestMlife Diagnostics, LLCNGM2026-07-20
G474M2117010mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-07-20
10722066018009Rapid ResponseBTNX IncQAW2026-07-14
10722066018009Rapid ResponseBTNX IncNGM2026-07-14
10722066018009Rapid ResponseBTNX IncNGL2026-07-14
10722066018009Rapid ResponseBTNX IncNGG2026-07-14
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNGM2026-07-09
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNGG2026-07-09
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNGL2026-07-09
00810174471229Prime Screen®WONDFO USA CO., LTD.NGL2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NGL2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NGG2026-06-26
10722066015053Rapid ResponseBTNX IncQAW2026-05-15