RANDOX LABORATORIES LIMITED

Address:30 RANDALSTOWN ROAD,ANTRIM Antrim and Newtownabbey,GB

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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

Nadh Oxidation/Nad Reduction, Alt/Sgpt (CKA) (9) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (1)

Premarket Exempt

No Yes

Clear

ALANINE AMINOTRANSFERASE (ALT) - 05055273200133 Catalog Number : AL100

Device Class : 1

Duns Number: 227530649

Premarket Exempt : No

Product Code : CKA

Prescription Use : Yes

Device Count : 1

ASSAYED BOVINE MULTI SERA - LEVEL 1 (BOV ASY CONTROL 1) - 05055273200140 Catalog Number :

Device Class : 1

Duns Number: 227530649

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

ALANINE AMINOTRANSFERASE (ALT) - 05055273200157 Catalog Number : AL1200

Device Class : 1

Duns Number: 227530649

Premarket Exempt : No

Product Code : CKA

Prescription Use : Yes

Device Count : 1

ALANINE AMINOTRANSFERASE (ALT) - 05055273200164 Catalog Number : AL1205

Device Class : 1

Duns Number: 227530649

Premarket Exempt : No

Product Code : CKA

Prescription Use : No

Device Count : 1

ALANINE AMINOTRANSFERASE (ALT) - 05055273200171 Catalog Number : AL1268

Device Class : 1

Duns Number: 227530649

Premarket Exempt : No

Product Code : CKA

Prescription Use : Yes

Device Count : 1

ALANINE AMINOTRANSFERASE (ALT) - 05055273200188 Catalog Number : AL146

Device Class : 1

Duns Number: 227530649

Premarket Exempt : No

Product Code : CKA

Prescription Use : Yes

Device Count : 1

ALANINE AMINOTRANSFERASE (ALT) - 05055273200195 Catalog Number : AL2360

Device Class : 1

Duns Number: 227530649

Premarket Exempt : No

Product Code : CKA

Prescription Use : Yes

Device Count : 1

ALT - 05055273200218 Catalog Number : AL3801

Device Description : An ALT test system is a device intended for the quantitative in vitro determinat An ALT test system is a device intended for the quantitative in vitro determination of Alanine Aminotransferase (ALT) activity in serum and plasma.

Device Class : 1

Duns Number: 227530649

Premarket Exempt : No

Product Code : CKA

Prescription Use : Yes

Device Count : 1

ALT - 05055273200225 Catalog Number : AL3875

Device Description : An ALT test system is a device intended for the quantitative in vitro determinat An ALT test system is a device intended for the quantitative in vitro determination of of Alanine Aminotransferase (ALT) activity in serum and plasma.

Device Class : 1

Duns Number: 227530649

Premarket Exempt : No

Product Code : CKA

Prescription Use : Yes

Device Count : 1

ALANINE AMINOTRANSFERASE (ALT) - 05055273200232 Catalog Number : AL7904

Device Class : 1

Duns Number: 227530649

Premarket Exempt : No

Product Code : CKA

Prescription Use : Yes

Device Count : 1

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