Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008416529

FEI Number

3008416529

Entity Name

MICRO DISTRIBUTING II, LTD.

City/State/Country

Belton, TX, US

Establishment Address

620 Kennedy Ct, Belton, TX 76513, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Micro Distributing II, Ltd. (Owner Number: 10051894)

Owner / Operator Contact Address

620 Kennedy Court, Belton, TX 76513, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K121166

PMA Number

N/A

All Registered Proprietary Names

STAT CASSETTE STAT CUPII STAT CUP STAT DIP STATCASSETTE STATCUP II STATCUP STATDIP STATCASSETTE STATCUP STATDIP STATCUP II STATCUP STATCUP II STATCASSETTE STATDIP STAT CUP STAT CASSETTE STAT CUPII STAT DIP STATCASSETTE STATCUP II STATDIP STATCUP STATCASSETTE STATCUP II STATDIP STATCUP STATCUP II STATDIP STATCUP II STATDIP STATDIP STATCUP II

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2016-05-17
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2016-05-17
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2016-05-17
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2016-05-17
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2016-05-17
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2016-05-17
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2019-12-27
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2019-12-27
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2019-12-27
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2019-12-27
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2019-12-27
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2019-12-27
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2019-12-27
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2019-12-27
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2019-12-27
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2016-05-17
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2016-05-17
DKE	Reagents, Test, Tetrahydrocannabinol	Clinical Toxicology	Class 2	862.3870	2016-05-17
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2016-05-17
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2016-05-17
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2016-05-17
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2019-12-27
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2019-12-27
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2019-12-27
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2019-12-27
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2019-12-27
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2019-12-27
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2019-12-27
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2019-12-27
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2019-12-27
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2019-12-27
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2019-12-27
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2019-12-27
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2019-12-27
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2019-12-27
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2019-12-27
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2019-12-27
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2019-12-27
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2019-12-27
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2019-12-27
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2019-12-27
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2019-12-27
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2019-12-27
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2019-12-27
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2019-12-27
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2019-12-27
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2019-12-27
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2019-12-27
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2019-12-27
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2019-12-27

Official Correspondent

David Wilks

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Micro Distributing II, Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K121166	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL	2012-05-08
K112236	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST	2011-09-19
K153050	Co-Innovation Biotech Co., Ltd.	Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard	2016-04-26
K151478	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo CR3 Keyless Split Sample Cup	2015-07-01
K150179	Guangzhou Wondfo Biotech Co., Ltd.	CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids	2015-02-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2013	Alere San Diego, Inc.	2	Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.
Z-2787-2018	Guangzhou Wondfo Biotech Co., Ltd.	2	TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,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.
Z-2788-2018	Guangzhou Wondfo Biotech Co., Ltd.	2	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.
Z-2789-2018	Guangzhou Wondfo Biotech Co., Ltd.	2	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.
Z-0006-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008416529. Last updated year: 2026. Please use registration number 3008416529 when referencing this establishment in official correspondence.