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

Device Class : 2

Duns Number: 227530649

Premarket Exempt : No

Product Code : CJW

Prescription Use : Yes

Device Count : 1

ALB - 05055273200041 Catalog Number : AB362

Device Description : An Albumin test system is a device intended for the quantitative in vitro determ

Device Class : 2

Duns Number: 227530649

Premarket Exempt : No

Product Code : CIX

Prescription Use : Yes

Device Count : 1

ALB - 05055273200058 Catalog Number : AB3800

Device Description : An Albumin test system is a device intended for the quantitative in vitro determ

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

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

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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