Hemocue AB

Address:KUVETTGATAN 1,ANGELHOLM Skane,SE

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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

System, Hemoglobin, Automated (GKR) (4) Glucose Oxidase, Glucose (CGA) (3) Automated Urinalysis System (KQO) (1) Calculator/Data Processing Module, For Clinical Use (JQP) (1) Counter, Cell, Automated (Particle Counter) (GKL) (1)

Premarket Exempt

No Yes

Clear

HemoCue® Hb301 Analyzer - 07311091218278 Catalog Number : 121827

Device Description : HemoCue Hb301 Analyzer g/dL

Device Class : 2

Duns Number: 356164426

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 1

HemoCue® Hb 801 Analyzer - 07311091219206 Catalog Number : 121920

Device Description : HemoCue Hb 801 Analyzer g/dL

Device Class : 2

Duns Number: 356164426

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 1

HemoCue® WBC Analyzer - 07311091230010 Catalog Number : 123001

Device Description : HemoCue WBC Analyzer x10^9 /L

Device Class : 2

Duns Number: 356164426

Premarket Exempt : No

Product Code : GKL

Prescription Use : Yes

Device Count : 1

HemoCue® 801 Connect - 07311091391681 Catalog Number : 139168

Device Description : HemoCue® 801 Connect

Device Class : 1

Duns Number: 356164426

Premarket Exempt : Yes

Product Code : JQP

Prescription Use : Yes

Device Count : 1

HemoCue® Plasma/Low Hb Microcuvettes - 17311091103021 Catalog Number : 110302

Device Description : HemoCue Plasma/Low Hb Microcuvettes 4x25 vial

Device Class :

Duns Number: 356164426

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 25

HemoCue® Urine Albumin Microcuvettes - 17311091106084 Catalog Number : 110608

Device Description : HemoCue Urine Albumin Microcuvettes 2x25 single

Device Class :

Duns Number: 356164426

Premarket Exempt : Yes

Product Code : KQO

Prescription Use : Yes

Device Count : 1

HemoCue® Glucose 201 Microcuvettes - 17311091107050 Catalog Number : 110705

Device Description : HemoCue Glucose 201 Microcuvettes 4x25 single

Device Class : 2

Duns Number: 356164426

Premarket Exempt : No

Product Code : CGA

Prescription Use : Yes

Device Count : 1

HemoCue® Glucose 201 Microcuvettes - 17311091107067 Catalog Number : 110706

Device Description : HemoCue Glucose 201 Microcuvettes 4x25 vial

Device Class :

Duns Number: 356164426

Premarket Exempt : No

Product Code : CGA

Prescription Use : Yes

Device Count : 25

HemoCue® Glucose 201 Microcuvettes - 17311091107234 Catalog Number : 110723

Device Description : HemoCue Glucose 201 Microcuvettes 2x25 single

Device Class : 2

Duns Number: 356164426

Premarket Exempt : No

Product Code : CGA

Prescription Use : Yes

Device Count : 1

HemoCue® Hb 201 Microcuvettes - 17311091117158 Catalog Number : 111715

Device Description : HemoCue Hb 201 Microcuvettes 4x25 single

Device Class : 2

Duns Number: 356164426

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 1

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