SmarLumi (UDI 06933289857697)
Manufactured by Guangzhou Wondfo Biotech Co., Ltd.
Device Regulatory Overview
The SmarLumi (Model/Catalog Number: W387P0005) is a medical device manufactured by Guangzhou Wondfo Biotech Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W01021312 within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- W387P0005
- Product Code / EMDN
- W01021312
- Device Name
- Lipoprotein-Associated Phospholipase A2 (CLIAοΌ
- Database Sync Date
- 2026-08-09 18:10:41
Full Regulatory Attributes
π Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of SmarLumi?
The registered manufacturer of record for SmarLumi is Guangzhou Wondfo Biotech Co., Ltd..
What is the Primary UDI-DI identifier for SmarLumi?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06933289857697.
What classification code is assigned to this device?
This device is registered under product classification code W01021312.
Similar Classification Devices (W01021312)
Other Devices by Guangzhou Wondfo Biotech Co., Ltd.
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- β TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO, MTD30,OPl40,OXY20, THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
- β TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
- β Automatic Glycohemoglobin Analyzer
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