RANDOX LABORATORIES LIMITED

Address:30 RANDALSTOWN ROAD,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

Bromcresol Green Dye-Binding, Albumin (CIX) (2) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2) Bromcresol Purple Dye-Binding, Albumin (CJW) (1) Acid Phosphatase, Naphthyl Phosphate (CKB) (1) Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase (CJC) (1) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (1) Calibrator, Secondary (JIT) (1) Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control (LKL) (1)

Premarket Exempt

No Yes

Clear

ALB - 05055273200034 Catalog Number : AB3800

Device Description : An Albumin test system is a device intended for the quantitative in vitro determ An Albumin test system is a device intended for the quantitative in vitro determination of Albumin concentration in serum and plasma.

Device Class : 2

Duns Number: 227530649

Premarket Exempt : No

Product Code : CJW

Prescription Use : Yes

Device Count : 1

ALB - 05055273200041 Catalog Number : AB362

Device Class : 2

Duns Number: 227530649

Premarket Exempt : No

Product Code : CIX

Prescription Use : Yes

Device Count : 1

ALB - 05055273200058 Catalog Number : AB3800

Device Class : 2

Duns Number: 227530649

Premarket Exempt : No

Product Code : CIX

Prescription Use : Yes

Device Count : 1

ACP - 05055273200065 Catalog Number : AC1011

Device Description : The acid phosphatase test system is intended for the quantitative in vitro deter The acid phosphatase test system is intended for the quantitative in vitro determination of Acid Phosphatase in serum.

Device Class : 2

Duns Number: 227530649

Premarket Exempt : No

Product Code : CKB

Prescription Use : Yes

Device Count : 1

ALDOLASE (ALS) - 05055273200072 Catalog Number :

Device Class : 1

Duns Number: 227530649

Premarket Exempt : Yes

Product Code : CJC

Prescription Use : Yes

Device Count : 1

ALS CAL - 05055273200089 Catalog Number : AD5000

Device Description : The Aldolase Calibration Serum is intended for in vitro diagnostic use, in the c The Aldolase Calibration Serum is intended for in vitro diagnostic use, in the calibration of the Aldolase assay AD189.

Device Class : 2

Duns Number: 227530649

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

ALDOLASE LEVEL 2 CONTROL (ALS CONTROL 2) - 05055273200096 Catalog Number : AD5001

Device Class : 1

Duns Number: 227530649

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

ALDOLASE LEVEL 3 CONTROL (ALS CONTROL 3) - 05055273200102 Catalog Number : AD5002

Device Class : 1

Duns Number: 227530649

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

ASSAYED BOVINE MULTI SERA - LEVEL 3 (BOV ASY CONTROL 3) - 05055273200119 Catalog Number :

Device Class : 1

Duns Number: 227530649

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 1

ALPHA-1-ACID-GLYCOPROTEIN (AGT) - 05055273200126 Catalog Number :

Device Class : 1

Duns Number: 227530649

Premarket Exempt : Yes

Product Code : LKL

Prescription Use : No

Device Count : 1

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