Product Specifications
| Specification | Details |
| Manufacturer / Brand | Wondfo USA Co., Ltd. / SAFElife™ C-Cup® |
| Manufacturer # / SKU | CDOA-13125EFA3 |
| CLIA / Regulatory Status | Forensic Use Only (FUO) |
| Sample Type | Human Urine |
| Read Time | 5 Minutes |
| Accuracy Rate | Up to 99% agreement with reference methods |
| Panels Tested (13 Drugs) | AMP, BUP, BZO, COC, EDDP, EtG, FTY, MDMA, MET, MOP, OXY, THC |
| Adulterant Testing (SVT) | Creatinine (CR), Specific Gravity (S.G.), pH |
| Temperature Strip | Integrated (90°F to 100°F / 32°C to 38°C) |
| Storage Temperature | 4°C to 30°C (39°F to 86°F) (Do not freeze) |
| Packaging Configuration | 25 Test Cups per Box |
| Latex / Sterility | Non-Sterile / Diagnostic Device |
Panel Configuration & Cutoff Levels
| Drug / Assay | Abbreviation | Cutoff Level |
| Amphetamine | AMP | 1,000 ng/mL |
| Buprenorphine | BUP | 10 ng/mL |
| Benzodiazepines | BZO | 300 ng/mL |
| Cocaine | COC | 300 ng/mL |
| Methadone Metabolite | EDDP | 300 ng/mL |
| Ethyl Glucuronide (Alcohol) | EtG | 500 ng/mL |
| Fentanyl | FTY | 20 ng/mL |
| Ecstasy | MDMA | 500 ng/mL |
| Methamphetamine | MET | 1,000 ng/mL |
| Opiates / Morphine | MOP | 300 ng/mL |
| Oxycodone | OXY | 100 ng/mL |
| Marijuana | THC | 50 ng/mL |
Key Features & Clinical Applications
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Custom 13-Panel Target Screening: Combines standard drugs of abuse with specialty forensic targets—including the direct methadone metabolite EDDP, Fentanyl (FTY), and the 80-hour alcohol metabolite Ethyl Glucuronide (EtG 500)—in a single collection cup.
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Integrated Specimen Validity Testing (SVT): Features a built-in 3-pad adulteration strip checking Creatinine (CR), Specific Gravity (S.G.), and pH to identify synthetic urine or specimen tampering.
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Temperature Verification Strip: Includes a rapid-reacting thermal strip directly on the cup exterior wall to confirm fresh specimen collection (90°F to 100°F) within 4 minutes.
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Compact Low-Volume Well: The specialized “C-Cup” design allows test strips to run efficiently even when low specimen volume is provided.
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Rapid Visual Interpretation: High-contrast visual lines appear within 5 minutes, allowing fast preliminary determinations.
⚠️ Preliminary Screening Notice: This rapid assay provides qualitative preliminary analytical test results only. A more specific alternative chemical method—such as Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) or Gas Chromatography-Mass Spectrometry (GC-MS)—must be used to obtain a confirmed quantitative analytical result.
⚠️ Regulatory Classification: Classified for Forensic Use Only (FUO). Not intended for clinical diagnostic decision-making or medical diagnostic use without confirmatory testing.
⚠️ Result Time Limit: Read test results strictly at 5 minutes. Do not interpret visual test lines after 10 minutes, as false readings may occur.
