FDA.reportPublic FDA data

Lyher

Primary DI
06972412611966
Brand
Lyher
Company
Hangzhou Laihe Biotech Co.,Ltd.
Model
DTH-101
Device description
The Urine Marijuana (THC) Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of THC-COOH in urine at the cut-off concentrations: Marijuana (THC) 50ng/mL.The test provides only a preliminary analytical test result. The test is not intended to be used in monitoring the drug levels. A more specific alternate method must be used in order to confirm the test result. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography/Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are obtained.
Published
2024-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232604000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232604000LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)Hangzhou Laihe Biotech Co., Ltd.2024-01-10LDJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972412611966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972412611966069724126119666972412611966

GMDN Terms#

Term, Definition table
TermDefinition
Cannabinoid/cannabinoid metabolite 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 cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) 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
543330912
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972412618897LYHERDOA-765DOA-7652026-05-06
06972412618569LyherDOA-1012024-11-12
06972412619696LyherDTH-1022024-11-12
06972412619405Lyher3030022024-11-11
06972412612000 femometerFM-IVY-1042024-04-25
06972412612017 femometerFM-IVY-1042024-04-25
06972412611836 femometerFM-IVY-1032023-05-29
06972412611843 femometerFM-IVY-1032023-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035554Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035707Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10722066008369Rapid ResponseBTNX IncLDJ2024-02-26
10722066005290Rapid Response Multi-Drug Integrated Split Spec. CupBTNX IncLDJ2023-04-28
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONLDJ2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONLDJ2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONLDJ2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10722066005139Rapid ResponseBTNX IncLDJ2020-06-03
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2020-05-29
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONLDJ2019-02-13
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2019-02-12
10694644500407RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONLDJ2018-12-05
10694644300755RDSAMERICAN BIO MEDICA CORPORATIONLDJ2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONLDJ2018-07-05
10694644500391RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONLDJ2018-06-20
10694644300731RDSAMERICAN BIO MEDICA CORPORATIONLDJ2018-05-23
10722355002573Detector Drug CupImmunostics Company, IncLDJ2018-05-21
10722355002580Detector Drug CupImmunostics Company, IncLDJ2018-05-21