ASCENSIA DIABETES CARE US INC.

Address:100 Summit Lake Drive,Valhalla,NY,10595,US

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Filters

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

Glucose Dehydrogenase, Glucose (LFR) (4) Method, Enzymatic, Glucose (Urinary, Non-Quantitative) (JIL) (4) Nitroprusside, Ketones (Urinary, Non-Quant.) (JIN) (4) System, Test, Blood Glucose, Over The Counter (NBW) (4)

Premarket Exempt

Yes No

Clear

DIASTIX® - 10301932803217 Catalog Number : 2803

Device Description : Reagent strips for urinalysis - glucose. 100 test strips.

Device Class :

Duns Number: 080028910

Premarket Exempt : No

Product Code : JIL

Prescription Use : No

Device Count : 100

DIASTIX® - 10301932806508 Catalog Number : 2806

Device Description : Reagent strips for urinalysis - glucose. 50 test strips.

Device Class :

Duns Number: 080028910

Premarket Exempt : No

Product Code : JIL

Prescription Use : No

Device Count : 50

KETOSTIX® - 10301932880508 Catalog Number : 2880

Device Description : Reagent Strips for Urinalysis: Ketone

Device Class :

Duns Number: 080028910

Premarket Exempt : No

Product Code : JIN

Prescription Use : No

Device Count : 50

KETOSTIX® - 10301932881215 Catalog Number : 2881

Device Description : Reagent Strips for Urinalysis: Ketone

Device Class :

Duns Number: 080028910

Premarket Exempt : No

Product Code : JIN

Prescription Use : No

Device Count : 100

KETO-DIASTIX® - 10301932882212 Catalog Number : 2882

Device Description : Reagent Strips for Urinalysis: Ketone; Glucose

Device Class :

Duns Number: 080028910

Premarket Exempt : No

Product Code : JIL, JIN

Prescription Use : No

Device Count : 100

KETO-DIASTIX® - 10301932883509 Catalog Number : 2883

Device Description : Reagent Strips for Urinalysis: Ketone; Glucose

Device Class :

Duns Number: 080028910

Premarket Exempt : No

Product Code : JIL, JIN

Prescription Use : No

Device Count : 50

CONTOUR® - 10301937070256 Catalog Number : 6707105

Device Description : Blood Glucose Test strips. 25 test strips.

Device Class :

Duns Number: 080028910

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : Yes

Device Count : 25

CONTOUR® - 10301937080507 Catalog Number : 7080G

Device Description : Blood Glucose Test strips. Sold in a carton with a single bottle (50 test strips Blood Glucose Test strips. Sold in a carton with a single bottle (50 test strips - NDC # 0193-7080-50), or in a carton of two bottles (100 test strips total - NDC # 0193-7090-21).

Device Class :

Duns Number: 080028910

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : Yes

Device Count : 50

CONTOUR® - 10301937097505 Catalog Number : 7097C

Device Description : Blood Glucose Test strips. 50 test strips.

Device Class :

Duns Number: 080028910

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : Yes

Device Count : 50

CONTOUR® - 10301937098502 Catalog Number : 7098C

Device Description : Blood Glucose Test strips. 50 test strips.

Device Class :

Duns Number: 080028910

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : Yes

Device Count : 50

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