BTNX Inc.

FDA Device Registration & Listing · Pickering Ontario, CA · Registration 3003917514

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
3003917514
FEI Number
3003917514
Entity Name
BTNX Inc.
City/State/Country
Pickering Ontario, CA
Establishment Address
722 Rosebank Road, Pickering Ontario L1W 4B2, CA
Establishment Type(s)
Foreign Private Label Distributor,Repack or Relabel Medical Device
Owner / Operator
BTNX Inc. (Owner Number: 9058575)
Owner / Operator Contact Address
722 Rosebank Road, PICKERING, CA-ON L1W 4B2, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K061559
PMA Number
N/A

All Registered Proprietary Names

Rapid Response Alcohol Breath Detector Rapid Response Multi-Drug Screen Cup Rapid Response Blood Glucose Monitoring System Rapid Response Drug Screening Saliva Test Rapid Response Single Drug Saliva Test Strip Rapid Response Multi-Drug Test Panel (Urine) Rapid Response Multi-Drug Test Cup (Urine) Rapid Response Drug Test Strip (Urine) Rapid Response Multi DOA Saliva Test Cup Rapid Response FIT - Fecal Immunochemical Test Rapid Response hCG Pregnancy Test (Cassette) Rapid Response Multi-Drug Test Cup (Urine) Rapid Response Single Drug Saliva Test Strip Rapid Response Multi DOA Saliva Test Cup Rapid Response Drug Test Strip (Urine) Rapid Response Drug Screening Saliva Test Rapid Response Multi-Drug Test Panel (Urine) Rapid Response COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) Rapid Response Drug Screen Panel Rapid Response Drug Test Strip (Urine) Rapid Response Drug Screening Saliva Test Rapid Response Single Drug Saliva Test Strip Rapid Response Multi-Drug Test Cup (Urine) Rapid Response Multi DOA Saliva Test Cup Rapid Response Multi-Drug Test Panel (Urine) Rapid Response Blood Glucose Monitoring System Rapid Response Drug Screening Saliva Test Rapid Response Drug Test Strip (Urine) Rapid Response Multi-Drug Test Panel (Urine) Rapid Response Multi-Drug Test Cup (Urine) Rapid Response Single Drug Saliva Test Strip Rapid Response Multi DOA Saliva Test Cup Rapid Response Multi-Drug Test Panel (Urine) Rapid Response Drug Screening Saliva Test Rapid Response Drug Test Strip (Urine) Rapid Response Single Drug Saliva Test Strip Rapid Response Multi-Drug Test Cup (Urine) Rapid Response Multi DOA Saliva Test Cup BTNX Inc. Rapid Response U500 Urine Analyzer Rapid Response Digital Pregnancy Test Rapid Response Multi-Drug Urine Test DipCard Rapid Response Multi-Drug Urine Test Cup Rapid Response At-Home Fentanyl Test Cassette Rapid Response Fentanyl Test Cassette Rapid Response Fentanyl Test Cassette (Urine) Rapid Response Multi-Drug Test Panel (Urine) Rapid Response Multi-Drug One Step Cup (Urine) Rapid Response One Step DOA Cup MOR 2000 (Urine) Rapid Response One Step DOA Cup MOR 300 (Urine) Rapid Response One Step DOA Test Cup (Urine) Rapid Response Single/Multi DOA Panel MOR 2000 (Urine) Rapid Response Single/Multi DOA Panel MOR 300 (Urine) Rapid Response Multi-Drug Test Cup Rapid Response LH Ovulation Test Rapid Response U120 Urine Analyzer BTNX Inc. Rapid Response UTI Urinary Tract Infection Test Strip Rapid Response Drug Screening Strip - OTC (Urine) Rapid Response Drug Screening Panel w/wo Adulteration (Urine) Rapid Response Drug Screening Cup - OTC (Urine) Rapid Response Drug Screening Cup w/wo Adulteration (Urine) Rapid Response Drug Screening Panel - OTC (Urine) Rapid Response Drug Screening Strip w/wo Adulteration (urine) L-Cup Home Rapid Test (Urine) L-Cup Rapid Test w/Adulteration (Urine) Rapid Response Strep A Test Strips BTNX Inc. Rapid Response hCG Pregnancy Test Strip OTC (Urine) (Strip) Rapid Response Multi DOA Saliva Test Cup Rapid Response Drug Screening Saliva Test Rapid Response Multi-Drug Test Cup (Urine) Rapid Response Multi-Drug Test Panel (Urine) Rapid Response Single Drug Saliva Test Strip Rapid Response Drug Test Strip (Urine) Rapid Response 720+ Urine Analyzer Rapid Response Single Drug Saliva Test Strip Rapid Response Multi-Drug Test Panel (Urine) Rapid Response Drug Test Strip (Urine) Rapid Response Multi DOA Saliva Test Cup Rapid Response Multi-Drug Test Cup (Urine) Rapid Response Drug Screening Saliva Test Rapid Response RSV Test Cassette BTNX Inc. Rapid Response Gluco-MD Blood Glucose Monitoring System BTNX Inc. Rapid Response hCG Pregnancy Test Strip (Urine) (Strip) Rapid Response Influenza AB + COVID-19 Antigen Detection Test (Anterior Nasal Swab) RAPID RESPONSE U120S URINE ANALYZER BTNX Inc. Rapid Response A1c System Rapid Response RSV Test Rapid Response Rotavirus Test Cassettes (Direct Ag/Visual) Rapid Response Drug Screen Cup Rapid Response Pregnancy Test 20mIU Rapid Response™ Safety Lancet Rapid Response Thyroid Stimulating Hormone (TSH) Test Cassette (Whole Blood) Rapid Response Strep A Test Rapid Response OTC Ovulation Test Rapid Response Single Drug Saliva Test Strip Rapid Response Drug Test Strip (Urine) Rapid Response Multi-Drug Test Cup (Urine) Rapid Response Drug Screening Saliva Test Rapid Response Multi DOA Saliva Test Cup Rapid Response Multi-Drug Test Panel (Urine) Rapid Response Microalbumin Creatinine Strips Rapid Response Strep A Rapid Test Strip BTNX Inc. Rapid Response Drugs of Abuse Test Cup BTNX Inc. Rapid Response Drugs of Abuse Test Panel BTNX Inc. Rapid Response Drugs of Abuse Test (Urine) Rapid Response Multi-Drug Test Panel Rapid Response Single-Drug Test Panel Rapid Response Single-Drug Test Strip Rapid Response Multi-Drug Integrated Split Spec. Cup Rapid Response Multi-Drug One-Step Cup Liquid Urine Control Teco Diagnostics Microalbumin 2-1 Combo Strip Rapid Response Microalbumin Creatinine Test Strip Rapid Response Single Drug Saliva Test Strip Rapid Response Drug Screening Saliva Test Rapid Response Multi DOA Saliva Test Cup Rapid Response Drug Test Strip (Urine) Rapid Response Multi-Drug Test Cup (Urine) Rapid Response Multi-Drug Test Panel (Urine) Rapid Response Influenza B Test Cassette Rapid Response Immunological Fecal Occult Blood Test (IFOBT) Rapid Response Fecal Immunochemical Test (FIT) BTNX Inc. Rapid Response LH Ovulation Test Cassette (Urine) Rapid Response Saliva Drug Test (COT) Rapid Response Saliva Drug Test (COT/THC) Plastic Collection Cup Rapid Response Pregnancy Combo Test Strip Rapid Response Pregnancy Test Strip Rapid Response Pregnancy Test Cassette Rapid Response Pregnancy Combo Cassette Rapid Response Influenza A Test Cassette Rapid Response Drug Monitoring Panel Rapid Response Home Drug Monitoring Panel Rapid Response Urinalysis Reagent Strips

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DJZ Devices, Breath Trapping, Alcohol Clinical Toxicology Class 1 862.3050 2011-08-31
QBF Test, Propoxyphene, Over The Counter Clinical Toxicology Class 2 862.3700 2025-09-09
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2025-09-09
NGI Test, Morphine, Over The Counter Clinical Toxicology Class 2 862.3640 2025-09-09
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2025-09-09
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2025-09-09
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2025-09-09
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2025-09-09
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2025-09-09
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2025-09-09
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2025-09-09
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2025-09-09
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2025-09-09
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2014-05-07
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2014-05-07
PUX Test, Amphetamine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3100 2021-11-29
KHE Reagent, Occult Blood Hematology Class 2 864.6550 2014-05-02
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2016-03-14
PVI Test, Propoxyphene, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3700 2022-09-30
QKO Reagent, Coronavirus Serological Unknown Class N N/A 2020-03-20
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2024-12-19
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2024-12-19
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2024-12-19
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2024-12-19
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2024-12-19
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2024-12-19
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2024-12-19
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2024-12-19
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2024-12-19
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2024-12-19
PUZ Test, Benzodiazepine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3170 2022-09-30
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2006-05-05
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2006-05-05
PVA Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3250 2022-09-30
PUY Test, Barbiturate, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3150 2022-09-30
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Clinical Chemistry Class 2 862.1340 2013-12-12
JRE Refractometer For Clinical Use Clinical Chemistry Class 1 862.2800 2013-12-12
KQO Automated Urinalysis System Clinical Chemistry Class 1 862.2900 2013-12-12
JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1115 2013-12-12
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) Clinical Chemistry Class 1 862.1550 2013-12-12
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1785 2013-12-12
NGJ Test, Nitrite, Urinary, Non-Quantitative, Over The Counter Clinical Chemistry Class 1 862.1510 2013-12-12
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2013-12-12
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2013-12-12
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2013-12-12
JMA Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) Clinical Chemistry Class 1 862.1095 2013-12-12
JIO Blood, Occult, Colorimetric, In Urine Hematology Class 2 864.6550 2013-12-12
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2024-11-19
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2018-06-06
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2018-06-06
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2018-06-06
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2018-06-06
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2018-06-06
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2018-06-06
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2018-06-06
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2018-06-06
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2018-06-06
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2018-06-06
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2018-06-06
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2024-02-29
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2024-02-29
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2023-11-08
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2018-05-25
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2018-05-25
QBF Test, Propoxyphene, Over The Counter Clinical Toxicology Class 2 862.3700 2018-05-25
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2018-05-25
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2018-05-25
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2018-05-25
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2018-05-25
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2018-05-25
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2018-05-25
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2018-05-25
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2018-05-25
CEP Radioimmunoassay, Luteinizing Hormone Clinical Chemistry Class 1 862.1485 2005-02-04
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2011-01-07
JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1115 2011-01-07
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2011-01-07
JRE Refractometer For Clinical Use Clinical Chemistry Class 1 862.2800 2011-01-07
JIO Blood, Occult, Colorimetric, In Urine Hematology Class 2 864.6550 2011-01-07
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1785 2011-01-07
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2011-01-07
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2011-01-07
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Clinical Chemistry Class 2 862.1340 2011-01-07
KQO Automated Urinalysis System Clinical Chemistry Class 1 862.2900 2011-01-07
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) Clinical Chemistry Class 1 862.1550 2011-01-07
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2016-08-05
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2016-08-05
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2019-06-20
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2019-06-20
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2019-06-20
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2019-06-20
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2019-06-20
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2019-06-20
DNK Thin Layer Chromatography, Morphine Clinical Toxicology Class 2 862.3640 2019-06-20
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2019-06-20
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2019-06-20
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2019-06-20
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2019-06-20
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2019-06-20
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2019-06-20
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2019-06-20
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2019-06-20
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2019-06-20
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2019-06-20
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2019-06-20
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2019-06-20
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2019-06-20
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2019-06-20
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2019-06-20
NGI Test, Morphine, Over The Counter Clinical Toxicology Class 2 862.3640 2019-06-20
GTY Antigens, All Groups, Streptococcus Spp. Microbiology Class 1 866.3740 2010-10-22
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2016-08-05
PVD Test, Methamphetamine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3610 2022-09-30
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) Clinical Chemistry Class 1 862.1550 2009-01-21
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2009-01-21
JRE Refractometer For Clinical Use Clinical Chemistry Class 1 862.2800 2009-01-21
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2009-01-21
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2009-01-21
JIO Blood, Occult, Colorimetric, In Urine Hematology Class 2 864.6550 2009-01-21
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Clinical Chemistry Class 2 862.1340 2009-01-21
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1785 2009-01-21
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2009-01-21
JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1115 2009-01-21
KQO Automated Urinalysis System Clinical Chemistry Class 1 862.2900 2009-01-21
PVH Test, Opiates, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3650 2022-09-30
GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus Microbiology Class 1 866.3480 2024-02-01
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2015-04-14
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2015-04-14
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2016-08-05
SCA Multi-Analyte Respiratory Virus Antigen Detection Test Microbiology Class 2 866.3987 2025-01-13
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2019-10-19
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2019-10-19
JRE Refractometer For Clinical Use Clinical Chemistry Class 1 862.2800 2019-10-19
KQO Automated Urinalysis System Clinical Chemistry Class 1 862.2900 2019-10-19
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1785 2019-10-19
JMA Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) Clinical Chemistry Class 1 862.1095 2019-10-19
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2019-10-19
JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1115 2019-10-19
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2019-10-19
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Clinical Chemistry Class 2 862.1340 2019-10-19
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) Clinical Chemistry Class 1 862.1550 2019-10-19
JIO Blood, Occult, Colorimetric, In Urine Hematology Class 2 864.6550 2019-10-19
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2018-06-04
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2018-06-04
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2018-06-04
GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus Microbiology Class 1 866.3480 2011-01-10
LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus Microbiology Class 1 866.3405 2011-10-18
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2024-09-26
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2024-09-26
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2024-09-26
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2024-09-26
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2024-09-26
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2024-09-26
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2024-09-26
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2024-09-26
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2024-09-26
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2024-09-26
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2013-03-04
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2020-08-13
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2013-03-08
GTY Antigens, All Groups, Streptococcus Spp. Microbiology Class 1 866.3740 2023-08-08
NGE Test, Luteinizing Hormone (Lh), Over The Counter Clinical Chemistry Class 1 862.1485 2013-05-20
PVE Test, Methadone, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3620 2022-09-30
JFY Enzymatic Method, Creatinine Clinical Chemistry Class 2 862.1225 2019-10-19
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2019-10-19
GTY Antigens, All Groups, Streptococcus Spp. Microbiology Class 1 866.3740 2011-10-25
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2018-04-24
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2018-04-24
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2018-04-24
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2018-04-24
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2018-04-24
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2018-04-24
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2018-04-24
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2018-04-24
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2018-04-24
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2017-07-28
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2017-07-28
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2017-07-28
JJW Urinalysis Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2012-02-10
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2010-07-13
JFY Enzymatic Method, Creatinine Clinical Chemistry Class 2 862.1225 2010-07-13
PVJ Test, Cannabinoid, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3870 2022-09-30
PSZ Devices Detecting Influenza A, B, And C Virus Antigens Microbiology Class 2 866.3328 2011-01-10
KHE Reagent, Occult Blood Hematology Class 2 864.6550 2010-07-05
CEP Radioimmunoassay, Luteinizing Hormone Clinical Chemistry Class 1 862.1485 2016-08-05
MKU Enzyme Immunoassay, Nicotine And Nicotine Metabolites Clinical Toxicology Class 1 862.3220 2024-02-21
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2024-02-21
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2024-09-03
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2021-07-19
PSZ Devices Detecting Influenza A, B, And C Virus Antigens Microbiology Class 2 866.3328 2011-01-10
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2025-09-09
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2025-09-09
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2025-09-09
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2025-09-09
QBF Test, Propoxyphene, Over The Counter Clinical Toxicology Class 2 862.3700 2025-09-09
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2025-09-09
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2025-09-09
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2025-09-09
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2025-09-09
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2025-09-09
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2025-09-09
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Clinical Chemistry Class 2 862.1340 2010-07-07
JRE Refractometer For Clinical Use Clinical Chemistry Class 1 862.2800 2010-07-07
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2010-07-07
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2010-07-07
JMA Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) Clinical Chemistry Class 1 862.1095 2010-07-07
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1785 2010-07-07
JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1115 2010-07-07
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) Clinical Chemistry Class 1 862.1550 2010-07-07
JIO Blood, Occult, Colorimetric, In Urine Hematology Class 2 864.6550 2010-07-07
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2010-07-07
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2010-07-07

Official Correspondent

Iqbal Sunderani

US Agent Details

Ryan O'callaghan Business: Phil Triolo and Associates LC Email: ryano@philt.com Phone: (801) 5732651

Related Public Records

Same Entity

BTNX Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3008741972 Lochness Medical Buffalo, NY, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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
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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0378-06 Instrumentation Laboratory Co. 2
GEM PREMIER 3000
Z-2165-2011 Instrumentation Laboratory Co. 2
Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-OXimetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acidlbase status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus
Z-0004-2009 Lifescan Inc 2
One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06 Abbott Laboratories Medisense Products 2
FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06 Abbott Laboratories Medisense Products 2
Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003917514. Last updated year: 2026. Please use registration number 3003917514 when referencing this establishment in official correspondence.
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