DrugCheck
DrugCheck SalivaScan is an oral-fluid drug-screening test with a configured panel of ten analytes in the filed 81026-EI example. It uses saliva as the specimen and is supplied as a test…
DrugCheck SalivaScan is an oral-fluid drug-screening test with a configured panel of ten analytes in the filed 81026-EI example. It uses saliva as the specimen and is supplied as a test device for screening rather than a laboratory analyzer.
The filed panel includes AMP, BAR, BZO, COC, MDMA, MET, MTD, OPI, OXY and THC. DrugCheck describes SalivaScan as a customizable oral-fluid test family, so other models may use different panels.
Listed Item
DrugCheck SalivaScan Oral Fluid Drug Test, AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI-OXY-THC
Panel Configuration
The device collects oral fluid and applies the selected panel configuration to the test. The model number distinguishes the specific analyte combination from other SalivaScan variants.
The listed example is a screening test. Its panel designation identifies targets included in this configuration, not a definitive clinical conclusion.
Who Else Makes It
Concentrated in Zhejiang (7), Guangdong (3), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| 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 |
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
| 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 |
| Weihai Kangzhou Biotechnology Engineering Co., Ltd. | Weihai | Shandong | Manufacturer | 24 |
| Hangzhou Lysun Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 22 |
| Hangzhou Tongzhou Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 14 |
Record
| Listed by | Express Diagnostic Int’l, Inc. |
|---|---|
| FDA product code | PVJ |
| Device type | Test, Cannabinoid, Employment And Insurance Testing, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3870 |
| Premarket notification | Exempt |
| Record published | 2020-03-12 |
| Record revised | 2022-06-10 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 80600-EI | In distribution | |
| 80800-EI | In distribution | |
| 80902-EI | In distribution | |
| 80140-EI | In distribution | |
| 81026-EI | In distribution | |
| 80617-EI | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Verify | Mlife Diagnostics LLC | 6 |
| Origin Instant Oral Drug Test | Origin Diagnostics LLC | 4 |
| Immunalysis | Immunalysis Corporation | 2 |
| T-Cube® | Instant Technologies, Inc. | 2 |
| Urine Dip Card | Instant Technologies, Inc. | 1 |
| MGC Health | Guangzhou Decheng Biotechnology Co., Ltd. | 1 |
| kangzhou | Weihai Kangzhou Biotechnology Engineering Co., Ltd. | 1 |
| UScreen® | Instant Technologies, Inc. | 1 |
| Origin Instant Drug Test | Origin Diagnostics LLC | 1 |
| HairCheck-DT (THC) Exempt | Quest Diagnostics, Inc. | 1 |
| iScreen™ | Instant Technologies, Inc. | 1 |
| Personal Care | Delta Brands Inc. | 1 |
Showing 12 of 15. All products under Test, Cannabinoid, Employment And Insurance Testing, Exempt
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.