Rapid Response
Rapid Response 10 Panel Saliva Test Cup E/I Screening (D10.3.2-2FC1E)- THC40, COC20, OPI40, AMP50, MET50, BAR50, BZO10, MDMA50, MTD30, PPX50. For employment and insurance testing.
7manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (6), Guangdong (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 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
| Eterbio, Inc. | Zhuhai | Guangdong | Manufacturer | 29 |
| Hangzhou Lysun Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 22 |
| Hangzhou Tongzhou Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 14 |
Record
| Listed by | Btnx Inc., Canada |
|---|---|
| FDA product code | PVI |
| Device type | Test, Propoxyphene, Employment And Insurance Testing, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3700 |
| Establishment | Repacker / relabeller, Private-label distributor, Complaint-file establishment, Exporter |
| Record published | 2022-12-07 |
| Record revised | 2023-04-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| D10.3.2-2FC1E | 25 | In distribution |
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.