Identity
- Trade Name
- Lyher FDA UDI
- Generic Name
- Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- DTH-102 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972412619696 FDA UDI
- 510(k) Number
- K232604 FDA UDI
- FDA Product Code
- LDJ FDA UDI
- GMDN Term
- Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3870 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Lyher by Hangzhou Laihe Biotech Co., Ltd. — Class II — IVDD, IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical.
- FIRSTVIEW Urine Test Marijuana DipCard — Safecare Biotech (Hangzhou) Co., Ltd. · Class II
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- AccuSign® DOA 3 TH/O/C card — PRINCETON BIOMEDITECH CORP. · Class II
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- Welcheck Marijuana(THC) Urine Test Dipcard — Safecare Biotech (Hangzhou) Co., Ltd. · Class II
Cleared under the same submission
K232604 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Hangzhou Laihe Biotech Co., Ltd.
Sources (2)
- FDA UDI 86a2f19c-3424-42eb-85bb-f7c398b71309 34 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 2, 2026