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

Multi-Analyte Controls, All Kinds (Assayed) (JJY) (3)

Premarket Exempt

No Yes

Clear

BLOOD GAS CONTROL - LEVEL 1 (BG CONTROL 1) - 05055273227109 Catalog Number : BG5001

Device Class : 1

Duns Number: 227530649

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

BLOOD GAS CONTROL - LEVEL 2 (BG CONTROL 2) - 05055273227116 Catalog Number : BG5002

Device Class : 1

Duns Number: 227530649

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

BLOOD GAS CONTROL - LEVEL 3 (BG CONTROL 3) - 05055273227123 Catalog Number : BG5003

Device Class : 1

Duns Number: 227530649

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

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