LZI Fentanyl III Enzyme Immunoassay
LZI Fentanyl III is a laboratory immunoassay for qualitative detection of fentanyl in human urine at a 1 ng/mL cutoff. It uses two ready-to-use liquid reagents on compatible automated…
LZI Fentanyl III is a laboratory immunoassay for qualitative detection of fentanyl in human urine at a 1 ng/mL cutoff. It uses two ready-to-use liquid reagents on compatible automated clinical chemistry analyzers.
Sample fentanyl competes with fentanyl-labelled glucose-6-phosphate dehydrogenase for antibody binding. Antibody-bound enzyme is inhibited; unbound enzyme converts NAD to NADH. The analyzer measures the resulting absorbance change at 340 nm relative to the cutoff.
Listed Item
Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL Enzyme Conjugate Reagent (R2): 37.5 mL
Reagents and Result Scope
R1 contains anti-fentanyl antibody, substrate and NAD; R2 contains the enzyme-labelled fentanyl conjugate. The filed small kit supplies these as separate bottles sold together. The result is preliminary and requires confirmation by a more specific chromatography/mass-spectrometry method.
Who Else Makes It
Concentrated in Zhejiang (9), Guangdong (4), Beijing (2). 5 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 |
| 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 |
| 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 17. All 17 manufacturers in China registered for Enzyme Immunoassay, Opiates
Record
| Listed by | LIN-ZHI International, Inc., United States |
|---|---|
| FDA product code | DJG |
| Device type | Enzyme Immunoassay, Opiates |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3650 |
| Establishment | Manufacturer |
| 510(k) | K251634 |
| Record published | 2026-07-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0970 | In distribution | |
| 0971 | In distribution | |
| C82916 | In distribution | |
| D29739 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Advin Multi-Drug Screen Test | Advin Biotech, Inc. | 75 |
| MD DugScreen | Medical Disposables Corp | 37 |
| Immunalysis | Immunalysis Corporation | 37 |
| DrugCheck | Express Diagnostics Int’l., Inc. | 29 |
| DOA 6 Panel Test | Rapid Diagnostics, Inc. | 28 |
| First Sign® | Hemosure Inc. | 20 |
| Enzyme Immunoassay, Opiates | W.h.p.m., Inc. | 20 |
| DrugCheck | Express Diagnostic Int’l, Inc. | 19 |
| MD DrugScreen | Medical Disposables Corp | 18 |
| DOA-7 Panel Test | Rapid Diagnostics, Inc. | 18 |
| DOA 5 Panel Test | Rapid Diagnostics, Inc. | 16 |
| Rapid Response | Btnx Inc. | 14 |
Showing 12 of 316. All products under Enzyme Immunoassay, Opiates
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253082 | 2026-01-16 |
| K251634 | 2025-06-18 |
| K202007 | 2020-09-17 |
| K201938 | 2020-08-07 |
| K201223 | 2020-06-04 |
| K181159 | 2018-12-03 |
| K141205 | 2015-02-13 |
| K141055 | 2014-06-13 |
| K120763 | 2012-06-01 |
| K120761 | 2012-05-08 |
| K110298 | 2011-07-15 |
| K101195 | 2010-07-06 |
| K090844 | 2009-07-30 |
| K081008 | 2008-12-22 |
| K050733 | 2005-06-13 |
| K020368 | 2002-06-04 |
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-02-18 | Class III | Packaging | Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality control testing. The cutoff calibrator was recovering at a concentration close to the NBUP Control Level 1 (7 ng/mL). | 120 units, 60 of each lot number | 2014-04-25 |
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.