RANDOX LABORATORIES LIMITED

Address:36 / 44 LARGY ROAD,CRUMLIN, CO.ANTRIM Antrim and Newtownabbey,GB

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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

Hemoglobinometer (GIG) (3) Saccharogenic, Amylase (CIJ) (3) Calibrator, Secondary (JIT) (1) Catalytic Methods, Amylase (JFJ) (1) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (1) System, Test, Beta-2-Microglobulin Immunological (JZG) (1)

Premarket Exempt

No Yes

Clear

AMY - 05055273200645 Catalog Number : AY7931

Device Description : An α-amylase test system is a device intended for the quantitative in vitro dete An α-amylase test system is a device intended for the quantitative in vitro determination of α-amylase activity in serum, plasma or urine.

Device Class : 2

Duns Number: 227530649

Premarket Exempt : No

Product Code : CIJ

Prescription Use : Yes

Device Count : 1

AMY - 05055273200652 Catalog Number : AY7932

Device Class : 2

Duns Number: 227530649

Premarket Exempt : No

Product Code : CIJ

Prescription Use : Yes

Device Count : 1

P AMY - 05055273200669 Catalog Number : AY7934

Device Description : The device is intended for the quantitative in vitro determination of pancreatic The device is intended for the quantitative in vitro determination of pancreatic α amylase in serum, plasma and urine.

Device Class : 2

Duns Number: 227530649

Premarket Exempt : No

Product Code : JFJ

Prescription Use : Yes

Device Count : 1

AMY - 05055273200676 Catalog Number : AY9707

Device Class : 2

Duns Number: 227530649

Premarket Exempt : No

Product Code : CIJ

Prescription Use : Yes

Device Count : 1

BILIRUBIN ELEVATED SERUM (BIL CONTROL H) - 05055273200706 Catalog Number :

Device Class : 1

Duns Number: 227530649

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

BETA 2 MICROGLOBULIN CALIBRATOR (B2M CAL) - 05055273200768 Catalog Number :

Device Class : 2

Duns Number: 227530649

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : No

Device Count : 1

B2Microglobulin (B2M) - 05055273200775 Catalog Number :

Device Class : 2

Duns Number: 227530649

Premarket Exempt : Yes

Product Code : JZG

Prescription Use : No

Device Count : 1

T BIL - 05055273200782 Catalog Number : BR2361

Device Description : The device is intended for the quantitative in vitro determination of total bili The device is intended for the quantitative in vitro determination of total bilirubin in serum or plasma.

Device Class : 2

Duns Number: 227530649

Premarket Exempt : No

Product Code : GIG

Prescription Use : Yes

Device Count : 1

D BIL - 05055273200799 Catalog Number : BR2362

Device Description : The device is intended for the quantitative in vitro determination of direct bil The device is intended for the quantitative in vitro determination of direct bilirubin in serum or plasma.

Device Class : 2

Duns Number: 227530649

Premarket Exempt : No

Product Code : GIG

Prescription Use : Yes

Device Count : 1

D BIL - 05055273200812 Catalog Number : BR2801

Device Description : The DBIL method used on the Dimension clinical chemistry system is an in vitro d The DBIL method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of direct (conjugated) bilirubin in serum or plasma.

Device Class : 2

Duns Number: 227530649

Premarket Exempt : No

Product Code : GIG

Prescription Use : Yes

Device Count : 1

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