BTNX Inc

Address:722 Rosebank Road,Pickering Ontario,CA

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (3) Enzyme Immunoassay, Cannabinoids (LDJ) (3) Enzyme Immunoassay, Amphetamine (DKZ) (3) Enzyme Immunoassay, Opiates (DJG) (3) Enzyme Immunoassay, Benzodiazepine (JXM) (3) Thin Layer Chromatography, Methamphetamine (DJC) (3) Visual, Pregnancy Hcg, Prescription Use (JHI) (2) Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) (JJB) (2) Blood, Occult, Colorimetric, In Urine (JIO) (2) Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) (CDM) (2) Enzyme Immunoassay, Barbiturate (DIS) (2) Enzyme Immunoassay, Methadone (DJR) (2) Enzyme Immunoassay, Phencyclidine (LCM) (2) Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) (JIR) (2) Kit, Test, Pregnancy, Hcg, Over The Counter (LCX) (2) Method, Enzymatic, Glucose (Urinary, Non-Quantitative) (JIL) (2) Nitroprusside, Ketones (Urinary, Non-Quant.) (JIN) (2) Test, Urine Leukocyte (LJX) (2) Test, Nitrite, Urinary, Non-Quantitative, Over The Counter (NGJ) (1) Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) (JMA) (1) Automated Urinalysis System (KQO) (1) Radioimmunoassay, Thyroid-Stimulating Hormone (JLW) (1) Dye-Indicator, Ph (Urinary, Non-Quantitative) (CEN) (1) Dye-Indicator, Ph (Urinary, Non-Quant.) (CEN) (1) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (1) Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) (JMT) (1) Reagent, Occult Blood (KHE) (1) Enzyme Linked Immunoabsorbent Assay, Rotavirus (LIQ) (1) Refractometer For Clinical Use (JRE) (1)

Premarket Exempt

No Yes

Clear

Rapid Response - 00722066000892 Catalog Number : D6.1-1P29-25

Device Description : Rapid Response Multi Drug Integrated Split Specimen Cups (COC,AMP,MET,THC,OPI,BZ Rapid Response Multi Drug Integrated Split Specimen Cups (COC,AMP,MET,THC,OPI,BZO) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Opiates, Benzodiazepines, Cocaine and THC metabolites in urine.

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : DIO, LDJ, JXM, DJG, DKZ, DJC

Prescription Use : Yes

Device Count : 25

Rapid Response - 00722066000908 Catalog Number : D10.1-1G29

Device Description : Rapid Response Multi Drug Integrated Split Specimen Cup (AMP,BAR,BZO,COC,MET,MTD Rapid Response Multi Drug Integrated Split Specimen Cup (AMP,BAR,BZO,COC,MET,MTD,OPI,PCP,TCA,THC) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Barbiturates, Benzodiazepines, Methadone, Opiates, Phencyclidine, Tricyclic-Antidepressant, Cocaine and THC metabolites in urine.

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : LCM, LFG, DIS, JXM, DIO, LDJ, DJG, DJR, DJC, DKZ

Prescription Use : Yes

Device Count : 25

Rapid Response - 00722066000915 Catalog Number : D10.3-1G29-25

Device Description : Rapid Response Multi Drug Integrated Split Specimen Cups (COC/AMP/MET/THC/OPI/PC Rapid Response Multi Drug Integrated Split Specimen Cups (COC/AMP/MET/THC/OPI/PCP/BAR/BZO/MTD/MDMA) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Opiates, Phencyclidine, Barbiturates, Benzodiazepines, Methadone, 3,4-Methylenedioxy-Methamphetamine, Cocaine and THC metabolites in urine.

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : LCM, DIS, JXM, DIO, LDJ, DJG, DJR, DJC, DKZ

Prescription Use : Yes

Device Count : 25

Rapid Response - 00722066001042 Catalog Number : HCG-1S50

Device Description : Rapid Response hCG Pregnancy Test Strips - 50 tests/ kit are for the qulitative Rapid Response hCG Pregnancy Test Strips - 50 tests/ kit are for the qulitative detection of Human Chorionic Gonadotropin in urine.

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : JHI, LCX

Prescription Use : Yes

Device Count : 50

Rapid Response - 00722066001172 Catalog Number : U10.1-1S100

Device Description : Rapid Response 10 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT/KET/P Rapid Response 10 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT/KET/PH/BIL/URO/SG) - 100 tests/ kit are for qualitative or semi-quantitative determination of Glucose, Blood, Leukocyte, Protein, Nitrite, Ketone, pH, Bilirubin, Urobilinogen, Specific Gravity in urine.

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : JJB, CDM, JIN, JIR, JMT, CEN, LJX, JIO, JIL

Prescription Use : Yes

Device Count : 100

Rapid Response - 00722066001202 Catalog Number : HCG-1S100

Device Description : Rapid Response hCG Pregnancy Test Strips - 100 tests/ kit are for the qulitative Rapid Response hCG Pregnancy Test Strips - 100 tests/ kit are for the qulitative detection of Human Chorionic Gonadotropin in urine.

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : JHI, LCX

Prescription Use : Yes

Device Count : 100

Rapid Response - 00722066001219 Catalog Number :

Device Description : Urine Analyzer 500

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : KQO, NGJ, LJX, JRE, JMA, JJB, JIR, JIO, JIN, JIL, CEN, CDM

Prescription Use : No

Device Count : 1

Rapid Response - 00722066001646 Catalog Number : TSH-13C20

Device Description : Rapid Response Thyroid Stimulating Hormone Test Cassettes - 20 tests/ kit are fo Rapid Response Thyroid Stimulating Hormone Test Cassettes - 20 tests/ kit are for the qualitative detection of TSH in serum, plasma or whole blood.

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : JLW

Prescription Use : Yes

Device Count : 20

Rapid Response - 00722066001882 Catalog Number : FOB-9C36

Device Description : Rapid Response Fecal Immunochemical Test - 36 tests/ kit are for the qualitative Rapid Response Fecal Immunochemical Test - 36 tests/ kit are for the qualitative detection of human hemoglobin in feces.

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 36

Rapid Response - 00722066001899 Catalog Number : ROT-9C20

Device Description : Rapid Response Rotavirus Test Cassettes - 20 tests/ kit are for qualitative dete Rapid Response Rotavirus Test Cassettes - 20 tests/ kit are for qualitative detection of rotavirus antigens in fecal specimens.

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : LIQ

Prescription Use : Yes

Device Count : 20

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