INNOVATION SCIENTIFIC PTY LTD

FDA Device Registration & Listing · Vineyard New South Wales, AU · Registration 3031697086

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3031697086
FEI Number
3031697086
Entity Name
INNOVATION SCIENTIFIC PTY LTD
City/State/Country
Vineyard New South Wales, AU
Establishment Address
7/16 Rob Place, Vineyard New South Wales 2765, AU
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Innovation Scientific Pty Ltd (Owner Number: 10093347)
Owner / Operator Contact Address
7/16 Rob Place, Vineyard, AU-NSW 2765, AU
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

DOA Urine Cup Multi-Drug Urine Test Panel Multi-Drug Urine Test Panel DOA Urine Cup Multi-Drug Urine Test Panel DOA Urine Cup Innochem DOA Urine Cup Multi-Drug Urine Test Panel

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2025-05-06
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2025-05-06
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2025-05-06
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2025-05-06
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2025-05-06
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2025-05-06
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2025-05-06
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2025-05-06
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2025-05-06
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2025-05-06
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2025-05-06
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2025-05-06
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2025-05-06
QBF Test, Propoxyphene, Over The Counter Clinical Toxicology Class 2 862.3700 2025-05-06
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2025-05-06
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2025-05-06
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2025-05-06
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2025-05-06
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2025-05-06
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2025-05-06
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2025-05-06
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2025-05-06
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2025-05-06
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2025-05-06
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2025-05-06
QBF Test, Propoxyphene, Over The Counter Clinical Toxicology Class 2 862.3700 2025-05-06
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2025-05-06
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2025-05-06
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2025-05-06
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2025-05-06
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2025-05-06
JJF Analyzer, Chemistry, Micro, For Clinical Use Clinical Chemistry Class 1 862.2170 2025-05-04
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2025-05-06
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2025-05-06
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2025-05-06
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2025-05-06
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2025-05-06
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2025-05-06
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2025-05-06
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2025-05-06
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2025-05-06
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2025-05-06
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2025-05-06

Official Correspondent

Anne Jones

US Agent Details

allen chen Business: Assure Tech LLC Email: allen.chen@diareagent.com Phone: (202) 8675908

Related Public Records

Same Entity

Innovation Scientific Pty 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
K241741 Guangzhou Wondfo Biotech Co., Ltd. SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel 2024-07-16
K252550 Guangzhou Wondfo Biotech Co., Ltd. SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx 2025-11-18
K202567 Guangzhou Wondfo Biotech Co., Ltd. Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx 2020-09-25
K260065 Guangzhou Wondfo Biotech Co., Ltd. SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx 2026-04-28
K182701 Guangzhou Wondfo Biotech Co., Ltd. Wondfo T-Cup Multi-Drug Urine Test Cup 2018-12-03

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0038-2020 Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands 1
V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
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 3031697086. Last updated year: 2026. Please use registration number 3031697086 when referencing this establishment in official correspondence.
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