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

Blood, Occult, Colorimetric, In Urine (JIO) (2) Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) (JMT) (2) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (2) Enzyme Immunoassay, Opiates (DJG) (2) Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) (JIR) (2) Method, Enzymatic, Glucose (Urinary, Non-Quantitative) (JIL) (2) Test, Urine Leukocyte (LJX) (2) Enzyme Immunoassay, Benzodiazepine (JXM) (2) Dye-Indicator, Ph (Urinary, Non-Quant.) (CEN) (1) Enzyme Immunoassay, Amphetamine (DKZ) (1) Test, Cocaine And Cocaine Metabolites, Over The Counter (NFY) (1) Thin Layer Chromatography, Amphetamine (DIT) (1) Nitroprusside, Ketones (Urinary, Non-Quant.) (JIN) (1)

Premarket Exempt

No Yes

Clear

Rapid Response - 00722066000373 Catalog Number : U5.1-1S100

Device Description : Rapid Response 5 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT) - 100 Rapid Response 5 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT) - 100 tests/ kit are for qualitative or semi-quantitative determination of Glucose, Blood, Leukocytes, Protein, Nitrite in urine.

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : JMT, JIR, LJX, JIO, JIL

Prescription Use : Yes

Device Count : 100

Rapid Response - 00722066000380 Catalog Number : U7.1-1S100

Device Description : Rapid Response 7 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT/KET/PH Rapid Response 7 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT/KET/PH) - 100 tests/ kit are for qualitative/ semi-quantitative determination of Glucose, Blood, Leukocytes, Protein, Nitrite, Ketone and pH in urine.

Device Class :

Duns Number: 251005005

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 100

Rapid Response - 00722066000441 Catalog Number : AMP-1C2-40

Device Description : Rapid Response Single Drug Test Cassettes (Amphetamine) - 40 tests/ kit are for Rapid Response Single Drug Test Cassettes (Amphetamine) - 40 tests/ kit are for the qualitative detection of Amphetamine in urine.

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : DKZ

Prescription Use : Yes

Device Count : 40

Rapid Response - 00722066000458 Catalog Number : AMP-1S2-100

Device Description : Rapid Response Single Drug Test Strips (AMP) - 100 tests/ kit are for the qualit Rapid Response Single Drug Test Strips (AMP) - 100 tests/ kit are for the qualitative detection of Amphetamine 1000 ng/ml in urine.

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : DIT

Prescription Use : Yes

Device Count : 100

Rapid Response - 00722066000489 Catalog Number :

Device Description : Single Drug Test Strip - 100/kit - Buprenorphine

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 100

Rapid Response - 00722066000496 Catalog Number :

Device Description : Single Drug Test Cassette - 40/kit Buprenorphine (BUP) - Cut off 10 ng/ml

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 40

Rapid Response - 00722066000502 Catalog Number : BZO-1S3-100

Device Description : Rapid Response Single Drug Test Strips (BZO) - 100 tests/ kit are for the qualit Rapid Response Single Drug Test Strips (BZO) - 100 tests/ kit are for the qualitative detection of Benzodiazipines in urine.

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : JXM

Prescription Use : Yes

Device Count : 100

Rapid Response - 00722066000519 Catalog Number : BZO-1C3-40

Device Description : Rapid Response Single Drug Test Cassettes (BZO) - 40 tests/ kit are for the qual Rapid Response Single Drug Test Cassettes (BZO) - 40 tests/ kit are for the qualitative detection of Benzodiazepines in urine.

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : JXM

Prescription Use : Yes

Device Count : 40

Rapid Response - 00722066000526 Catalog Number : COC-1S3-100

Device Description : Rapid Response Single Drug Test Strips (COC) - 100 tests/ kit are for the qualit Rapid Response Single Drug Test Strips (COC) - 100 tests/ kit are for the qualitative detection of cocaine metabolite in urine.

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : DIO, NFY

Prescription Use : Yes

Device Count : 100

Rapid Response - 00722066000533 Catalog Number : COC-1C3-40

Device Description : Rapid Response Single Drug Test Cassettes (COC) - 40 tests/ kit are for the qual Rapid Response Single Drug Test Cassettes (COC) - 40 tests/ kit are for the qualitative detection of cocaine metabolite in urine.

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : DIO

Prescription Use : Yes

Device Count : 40

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