Eurotrol B.V.

Address:KEPLERLAAN 20,EDE Gelderland,NL

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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

Control, Hemoglobin (GGM) (7) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (2) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1)

Premarket Exempt

No Yes

Clear

Eurotrol - 08718734960911 Catalog Number :

Device Class : 1

Duns Number: 412925992

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Eurotrol - 08718734960928 Catalog Number :

Device Description : Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each level.It is a convenience kit for the purposes of UDI compliance because it contains 5 different levels that are packaged together for the convenience of the user and intended to remain packaged together and not replaced, substituted, repackaged, sterilized or otherwise processed or modified before being used by an end user. Therefore, the label of each individual vial within the container is not required to bear a UDI,provided that a UDI is available on the label affixed to the immediate container of the kit.

Device Class : 1

Duns Number: 412925992

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Eurotrol GlucoTrol-AQ - 08718734960935 Catalog Number :

Device Description : Eurotrol GlucoTrol-AQ is an assayed glucose control intended for professional us Eurotrol GlucoTrol-AQ is an assayed glucose control intended for professional use in the verification of the precision and accuracy of the HemoCue Glucose 201 analyzer.A box of Eurotrol GlucoTrol-AQ contains 2 levels of control material:GlucoTrol-AQ Low (1): 08718734961536GlucoTrol-AQ High (3): 08718734961543

Device Class : 1

Duns Number: 412925992

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

HemoTrol WB - 08718734960973 Catalog Number : 08718734960942

Device Description : HemoTrol® WB is an assayed quality control material for professional use to veri HemoTrol® WB is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue ® Hb 301 and the HemoCue ® Hb 801 System. HemoTrol® WB is intended for the quantitative determination of hemoglobin.

Device Class :

Duns Number: 412925992

Premarket Exempt : No

Product Code : GGM

Prescription Use : Yes

Device Count : 1

HemoTrol WB - 08718734960980 Catalog Number : 08718734960959

Device Description : HemoTrol® WB is an assayed quality control material for professional use to veri HemoTrol® WB is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue® Hb 301 and the HemoCue® Hb 801 System. HemoTrol® WB is intended for the quantitative determination of hemoglobin.

Device Class : 2

Duns Number: 412925992

Premarket Exempt : No

Product Code : GGM

Prescription Use : Yes

Device Count : 1

HemoTrol WB - 08718734960997 Catalog Number : 08718734960966

Device Description : HemoTrol® WB is an assayed quality control material for professional use to veri HemoTrol® WB is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue® Hb 301 and the HemoCue® Hb 801 System. HemoTrol® WB is intended for the quantitative determination of hemoglobin.

Device Class : 2

Duns Number: 412925992

Premarket Exempt : No

Product Code : GGM

Prescription Use : Yes

Device Count : 1

CueSee® CO-OX - 08718734961000 Catalog Number : AN01486A01

Device Description : CueSee® CO-OX S1A is an assayed quality control material for professional use to CueSee® CO-OX S1A is an assayed quality control material for professional use to verify the performance characteristics of the Radiometer ABL800 FLEX series analyzer. CueSee® COOX is intended for the quantitative determination of total hemoglobin (tHb), fraction of oxygenated hemoglobin (FO2Hb), fraction of carboxyhemoglobin (FCOHb) and fraction of methemoglobin (FMetHb). CueSee® CO-OX is intended for professional users (medical and laboratory personnel) in clinical settings (e.g. hospital or laboratory).

Device Class :

Duns Number: 412925992

Premarket Exempt : Yes

Product Code : GGM

Prescription Use : Yes

Device Count : 1

CueSee® CO-OX - 08718734961024 Catalog Number : AN01486A03

Device Description : CueSee® CO-OX S3A is an assayed quality control material for professional use to CueSee® CO-OX S3A is an assayed quality control material for professional use to verify the performance characteristics of the Radiometer ABL800 FLEX series analyzer. CueSee® COOX is intended for the quantitative determination of total hemoglobin (tHb), fraction of oxygenated hemoglobin (FO2Hb), fraction of carboxyhemoglobin (FCOHb) and fraction of methemoglobin (FMetHb). CueSee® CO-OX is intended for professional users (medical and laboratory personnel) in clinical settings (e.g. hospital or laboratory).

Device Class : 2

Duns Number: 412925992

Premarket Exempt : Yes

Product Code : GGM

Prescription Use : Yes

Device Count : 1

CueSee® CO-OX - 08718734961048 Catalog Number : AN01486A03

Device Description : CueSee® CO-OX S5A is an assayed quality control material for professional use to CueSee® CO-OX S5A is an assayed quality control material for professional use to verify the performance characteristics of the Radiometer ABL800 FLEX series analyzer. CueSee® COOX is intended for the quantitative determination of total hemoglobin (tHb), fraction of oxygenated hemoglobin (FO2Hb), fraction of carboxyhemoglobin (FCOHb) and fraction of methemoglobin (FMetHb). CueSee® CO-OX is intended for professional users (medical and laboratory personnel) in clinical settings (e.g. hospital or laboratory).

Device Class : 2

Duns Number: 412925992

Premarket Exempt : Yes

Product Code : GGM

Prescription Use : Yes

Device Count : 1

CueSee® CO-OX - 08718734961086 Catalog Number : AN01486A04

Device Description : CueSee® CO-OX LVA is an assayed quality control material for professional use to CueSee® CO-OX LVA is an assayed quality control material for professional use to verify the performance characteristics of the Radiometer ABL800 FLEX series analyzer. CueSee® COOX is intended for the quantitative determination of total hemoglobin (tHb), fraction of oxygenated hemoglobin (FO2Hb), fraction of carboxyhemoglobin (FCOHb) and fraction of methemoglobin (FMetHb). CueSee® CO-OX is intended for professional users (medical and laboratory personnel) in clinical settings (e.g. hospital or laboratory).CueSee® CO-OX LVA contains: 1 bottle of CueSee® CO-OX S1A (DI: 08718734961000), 1 bottle of CueSee® CO-OX S2A (DI: 08718734961017), 1 bottle of CueSee® CO-OX S3A (DI: 08718734961024), 1 bottle of CueSee® CO-OX S4A (DI: 08718734961031) and 1 bottle of CueSee® CO-OX S5A (DI: 08718734961048).

Device Class : 2

Duns Number: 412925992

Premarket Exempt : Yes

Product Code : GGM

Prescription Use : Yes

Device Count : 1

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