Immunalysis
Immunalysis SEFRIA 6-Acetylmorphine Oral Fluid is an enzyme immunoassay reagent set for qualitative detection of 6-acetylmorphine in human oral fluid. The assay is intended for use with…
Immunalysis SEFRIA 6-Acetylmorphine Oral Fluid is an enzyme immunoassay reagent set for qualitative detection of 6-acetylmorphine in human oral fluid. The assay is intended for use with compatible clinical laboratory analyzers and produces a screening result for the named analyte.
The listed family includes multiple model and pack-size variants of the same oral-fluid assay. The filed 647OF-0100 example identifies the 6-acetylmorphine test, not the separate SEFRIA assays for other targets.
Listed Item
SEFRIA™ 6-Acetylmorphine Oral Fluid
Assay Role
The reagent assay reacts with 6-acetylmorphine in an oral-fluid specimen and reports the analyte result through an analyzer-based immunoassay workflow. It is a test reagent, not a sample collection swab or a standalone reader.
The manufacturer’s SEFRIA range includes target-specific oral-fluid assays. This page’s product is the 6-acetylmorphine version; the target should remain tied to that named assay.
Who Else Makes It
Concentrated in Zhejiang (6), 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 |
| 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 |
| Xiamen Boson Biotech Co., Ltd. | Xiamen | Fujian | Manufacturer | 6 |
Record
| Listed by | Immunalysis Corporation, United States |
|---|---|
| FDA product code | PVH |
| Device type | Test, Opiates, Employment And Insurance Testing, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3650 |
| Premarket notification | Exempt |
| Record published | 2018-06-22 |
| Record revised | 2024-04-10 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 621OF-0100 | In distribution | |
| 652OF-0100 | In distribution | |
| 647OF-0500 | In distribution | |
| 621OF-0500 | In distribution | |
| 607OF-0500 | In distribution | |
| 647OF-0100 | In distribution | |
| 607OF-0100 | In distribution | |
| 652OF-0500 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Statswab® | Micro Distributing, L.C | 5 |
| Urine Dip Card | Instant Technologies, Inc. | 2 |
| Noble Drug Test Cup (Urine) | Noble Medical Inc | 2 |
| Amazewell | Guangzhou Decheng Biotechnology Co., Ltd. | 1 |
| Quest Diagnostics Oral Fluid Oxycodone Heia | Quest Diagnostics, Inc. | 1 |
| T-Cube® | Instant Technologies, Inc. | 1 |
| Noble Drug Test Cup with AD (Urine) | Noble Medical Inc | 1 |
| Statswabii® | Micro Distributing, L.C | 1 |
| iSCREEN™ | Instant Technologies, Inc. | 1 |
| co-innovation | Co-Innovation Biotech Co., Ltd. | 1 |
| DrugCheck | Express Diagnostic Int’l, Inc. | 1 |
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.