Lyher
The LYHER® Urine Multi-Drug Test Kit (Cup), LYHER® Urine Multi- Drug Test Kit (Cassette) and LYHER® Urine Multi-Drug Test Kit (Dipcard) are rapid lateral flow immunoassays for the…
The LYHER® Urine Multi-Drug Test Kit (Cup), LYHER® Urine Multi- Drug Test Kit (Cassette) and LYHER® Urine Multi-Drug Test Kit (Dipcard) are rapid lateral flow immunoassays for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and THC-COOH in human urine. The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 6 analytes. The drug screen tests are intended for prescription use only. The tests provide only a preliminary result. A more specific alternative chemical method should be used in order to obtain a confirmed presumptive Positive result. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary Positive results.
Who Else Makes It
Concentrated in Zhejiang (9), Guangdong (3), Beijing (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
| Abon Biopharm (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
| Core Technology Co., Ltd. | Changping District | Beijing | Contract manufacturer | 14 |
| Prometheus Bio Inc. | Hangzhou | Zhejiang | Contract manufacturer | 12 |
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
| W.h.p.m. Bioresearch & Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 37 |
| Guangzhou Decheng Biotechnology Co., Ltd. | Guangzhou | Guangdong | Complaint-file establishment | 35 |
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Co-Innovation Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 29 |
Showing 12 of 16. All 16 manufacturers in China registered for Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Record
| Listed by | Hangzhou Laihe Biotech Co., Ltd., China |
|---|---|
| FDA product code | DIO |
| Device type | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3250 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K240287 |
| Record published | 2026-05-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DOA-765 | In distribution | |
| DOA-101 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Healgen | Healgen Scientific Limited Liability Company | 19 |
| iCup® | Instant Technologies, Inc. | 15 |
| DrugCheck | Express Diagnostics Int’l., Inc. | 12 |
| AlereTM iScreen® | Instant Technologies, Inc. | 9 |
| MD DugScreen | Medical Disposables Corp | 9 |
| Monitect Drug Screen Cassette Test | Branan Medical Corporation | 9 |
| First Sign® | Hemosure Inc. | 8 |
| Rapid Response | Btnx Inc. | 7 |
| Identify® Diagnostics Drug Test Cards | Medical Distribution Group Inc | 7 |
| iScreen™ | Instant Technologies, Inc. | 7 |
| SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup | Alere San Diego, Inc. | 7 |
| DrugCheck | Express Diagnostic Int’l, Inc. | 7 |
Showing 12 of 152. All products under Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.