THC Urine Strip Test
SAFECARE THC Urine Strip Test is a single-use test for a marijuana metabolite in human urine. It uses a competitive lateral-flow immunoassay to detect 11-nor-delta-9-THC-9-carboxylic acid…
SAFECARE THC Urine Strip Test is a single-use test for a marijuana metabolite in human urine. It uses a competitive lateral-flow immunoassay to detect 11-nor-delta-9-THC-9-carboxylic acid at a nominal cutoff of 50 ng/mL and is intended for over-the-counter use.
Urine travels along the strip by capillary action. Antibody-coated particles interact with the metabolite and an immobilized drug conjugate, producing a visible line pattern. A control band is designed to appear regardless of whether the target metabolite is present.
Preliminary Screening Result
The result is qualitative and preliminary. A more specific chemical method is needed to obtain a confirmed analytical result, with GC/MS or LC/MS identified as preferred confirmation methods. The test is supplied as a strip in a sealed pouch with desiccant and a package insert.
Who Else Makes It
Concentrated in Zhejiang (8), Guangdong (4), Tianjin (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
| Co-Innovation Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 29 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| 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 |
| Eterbio, Inc. | Zhuhai | Guangdong | Manufacturer | 29 |
| Safecare Biotech(Hangzhou)Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 22 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
Showing 12 of 16. All 16 manufacturers in China registered for Test, Cannabinoid, Over The Counter
Record
| Listed by | Safecare Biotech(Hangzhou)Co., Ltd., China |
|---|---|
| FDA product code | NFW |
| Device type | Test, Cannabinoid, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3870 |
| Establishment | Manufacturer |
| 510(k) | K191924 |
| Record published | 2023-02-16 |
| Record revised | 2025-10-24 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| THC-1011 | In distribution | |
| THC-1011 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Discover Plus | American Screening, L.L.C. | 47 |
| Discover | American Screening, L.L.C. | 43 |
| Precision DX | American Screening, L.L.C. | 42 |
| Reveal | American Screening, L.L.C. | 22 |
| OneScreen | American Screening, L.L.C. | 20 |
| Precision Plus | American Screening, L.L.C. | 12 |
| CVS Health | Woonsocket Prescription Center, Incorporated | 8 |
| Exploro Highly Sensitive THC Test | Safecare Biotech(Hangzhou)Co., Ltd. | 6 |
| Analysis Oasis Marijuana (THC) Urine Strip Test | Safecare Biotech(Hangzhou)Co., Ltd. | 5 |
| Walgreens | Walgreen Co. | 4 |
| UScreen® | Instant Technologies, Inc. | 4 |
| VeriCheck Drug Test Dip | Verify Diagnostics Inc | 4 |
Showing 12 of 43. All products under Test, Cannabinoid, Over The Counter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191924 | 2019-08-16 |
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.