SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182654 FDA 510(k)
- FDA Product Code
- NGG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3610 FDA 510(k)
- Regulation Number
- 862.3610 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SAFECARE Multi-Drug Urine Test Cup and Dip Card is a clinical toxicology device used for detecting multiple drug analytes in urine samples. The device can be configured with various combinations of drug analytes and may yield positive results for prescription drugs including Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses.
This device is supplied as a single-use test cup or dip card and is not indicated for MRI safety. It is authorized under FDA 510(k) clearance with product code NGG and K-number K182654. The device is manufactured by Safecare Biotech (Hangzhou) Co., Ltd. and is classified as Class II in Clinical Toxicology.
Frequently asked questions
What is the SAFECARE Multi-Drug Urine Test Cup used for?
The SAFECARE Multi-Drug Urine Test Cup and Dip Card is a clinical toxicology device used for detecting multiple drug analytes in urine samples. It can detect prescription drugs including Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses.
How is the SAFECARE Multi-Drug Urine Test Cup supplied?
The device is supplied as a single-use test cup or dip card. It is not indicated for MRI safety and is manufactured by Safecare Biotech (Hangzhou) Co., Ltd. Each test is designed for one-time use only.
What is the regulatory status of the SAFECARE Multi-Drug Urine Test Cup?
The device is authorized under FDA 510(k) clearance with product code NGG and K-number K182654. It is classified as Class II in Clinical Toxicology and received FDA clearance on November 19, 2018.
What analytes can the SAFECARE Multi-Drug Urine Test Cup detect?
The device can be configured with various combinations of drug analytes and may yield positive results for prescription drugs including Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Safecare Antigen Selbsttest günstig online kaufen | medplus, SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card, SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip ..., Safecare Covid-19 & Influenza A+B Kombi-Selbsttest, K181968 FDA 510(k) - SAFECARE Multi-Drug Urine Test Cup
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182654 | Class II | Active |
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Manufacturer
- Manufacturer
- Safecare Biotech (Hangzhou) Co., Ltd.
Sources (1)
- FDA 510(k) K182654 24 fields · synced Oct 6, 2026