ARKRAY USA, INC.

AUTION™ Staining Solution SED - 04987486738091 Catalog Number :

Device Description : Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Cells, and Bacteria as well as flags for pathologic casts, yeast, crystal, small round cells, mucus, and sperm in urine sediment.

Device Class : 1

Duns Number: 008171162

Premarket Exempt : No

Product Code : KQO

Prescription Use : No

Device Count : 1

AUTION™ Staining Solution BAC - 04987486738107 Catalog Number :

Device Description : Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Cells, and Bacteria as well as flags for pathologic casts, yeast, crystal, small round cells, mucus, and sperm in urine sediment.

Device Class : 1

Duns Number: 008171162

Premarket Exempt : No

Product Code : KQO

Prescription Use : No

Device Count : 1

AUTION™ Sheath Solution - 04987486738114 Catalog Number :

Device Description : Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Cells, and Bacteria as well as flags for pathologic casts, yeast, crystal, small round cells, mucus, and sperm in urine sediment.

Device Class : 1

Duns Number: 008171162

Premarket Exempt : No

Product Code : KQO

Prescription Use : No

Device Count : 1

Assure® Platinum Blood Glucose Meter - 30015482501779 Catalog Number :

Device Description : Assure Platinum Meter Institutional multi-pack (4 Assure Platinum meter kits PN 500001)

Device Class : 2

Duns Number: 008171162

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Assure® Prism Multi Blood Glucose Meter - 30015482531776 Catalog Number :

Device Description : Assure Prism Meter Institutional multi-pack (4 Assure Prism meter kits PN 530001)

Device Class : 2

Duns Number: 008171162

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

GLUCOCARD® Shine Blood Glucose Monitoring System - 30015482541997 Catalog Number :

Device Description : Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU

Device Class : 2

Duns Number: 008171162

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

GLUCOCARD® Shine XL Blood Glucose Monitoring System - 30015482542994 Catalog Number :

Device Description : Startup Portable Blood Glucose Meter System. Includes: blood glucose meter, te Startup Portable Blood Glucose Meter System. Includes: blood glucose meter, test strips, IFU

Device Class : 2

Duns Number: 008171162

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

GLUCOCARD® Expression™ Blood Glucose Monitoring System - 30015482571888 Catalog Number :

Device Description : DME: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU

Device Class : 2

Duns Number: 008171162

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 1

GLUCOCARD® Expression™ Blood Glucose Monitoring System - 30015482571994 Catalog Number :

Device Description : Retail: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU

Device Class : 2

Duns Number: 008171162

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

GLUCOCARD® Vital™ Blood Glucose Meter - 30015482761777 Catalog Number :

Device Description : GLUCOCARD Vital Meter Institutional multi-pack (4 GLUCOCARD Vital meter kits PN 760020)

Device Class : 2

Duns Number: 008171162

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

ARKRAY USA, INC.

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