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

Visual, Pregnancy Hcg, Prescription Use (JHI) (4) Method, Enzymatic, Glucose (Urinary, Non-Quantitative) (JIL) (2) Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) (JIR) (2) Blood, Occult, Colorimetric, In Urine (JIO) (1) Antigens, All Groups, Streptococcus Spp. (GTY) (1) Nitroprusside, Ketones (Urinary, Non-Quant.) (JIN) (1) System, Test, Infectious Mononucleosis (KTN) (1) Test, Urine Leukocyte (LJX) (1) Helicobacter Pylori (LYR) (1)

Premarket Exempt

No Yes

Clear

Rapid Response - 00722066000014 Catalog Number : STR-15S25

Device Description : Rapid Response Strep A Test Strips (throat swab) - 25 tests/ kit are for qualita Rapid Response Strep A Test Strips (throat swab) - 25 tests/ kit are for qualitative detection of Group A Streptococcal antigen from throat swab specimens.

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : GTY

Prescription Use : Yes

Device Count : 25

Rapid Response - 00722066000205 Catalog Number : HCG-3C50

Device Description : Rapid Response hCG Pregnancy Test Cassettes - 50 tests/ kit are for the qualitat Rapid Response hCG Pregnancy Test Cassettes - 50 tests/ kit are for the qualitative detection of Human Chlorionic Gonadotropin in urine/ serum.

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 50

Rapid Response - 00722066000229 Catalog Number : HCG-1C50

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 50

Rapid Response - 00722066000267 Catalog Number : HCG-3C25

Device Description : Rapid Response hCG Pregnancy Test Cassettes - 25 tests/ kit are for the qualitat Rapid Response hCG Pregnancy Test Cassettes - 25 tests/ kit are for the qualitative detection of Human Chorionic Gonadotropin in urine/ serum,

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 25

Rapid Response - 00722066000274 Catalog Number : HCG-1C25

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 25

Rapid Response - 00722066000304 Catalog Number : HPY-13C15

Device Description : Rapid Response H. Pylori Test Cassettes - 15 tests/ kit are for the qualitative Rapid Response H. Pylori Test Cassettes - 15 tests/ kit are for the qualitative detection of antibodies to Helicobacter pylori in whole blood, serum, or plasma.

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : LYR

Prescription Use : Yes

Device Count : 15

Rapid Response - 00722066000311 Catalog Number : MON-13C15

Device Description : Rapid Response Mononucleosis Test Cassettes - 15 tests/ kit are for the qualita Rapid Response Mononucleosis Test Cassettes - 15 tests/ kit are for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum or plasma.

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : KTN

Prescription Use : Yes

Device Count : 15

Rapid Response - 00722066000335 Catalog Number : U-KET-1S100

Device Description : Rapid Response 1 Parameter Urinalysis Reagent Strips (Ketone) - 100 strips/ kit Rapid Response 1 Parameter Urinalysis Reagent Strips (Ketone) - 100 strips/ kit are for the qualitative or semi-quantitative detection of Ketone in urine.

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : JIN

Prescription Use : Yes

Device Count : 100

Rapid Response - 00722066000342 Catalog Number : U2.1-1S100

Device Description : Rapid Response 2 Parameter Urinalysis Reagent Strips (Glu/Pro) - 100 tests/ kit Rapid Response 2 Parameter Urinalysis Reagent Strips (Glu/Pro) - 100 tests/ kit are for the qualitative or semi-quantitative detection of Glucose and Protein in urine.

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : JIL, JIR

Prescription Use : Yes

Device Count : 100

Rapid Response - 00722066000366 Catalog Number : U4.1-1S100

Device Description : Rapid Response 4 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO) - 100 tes Rapid Response 4 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO) - 100 tests/ kit are for qualitative or semi-quantitative determination of Glucose, Blood, Leukocytes, Protein in urine.

Device Class :

Duns Number: 251005005

Premarket Exempt : No

Product Code : JIR, LJX, JIO, JIL

Prescription Use : Yes

Device Count : 100

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