ABBOTT IRELAND

Address:DIAGNOSTICS DIVISION,SLIGO,IE

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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

CALIBRATOR, SECONDARY (JIT) (6) ACID, FOLIC, RADIOIMMUNOASSAY (CGN) (5) SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) (JJX) (5) FERRITIN, ANTIGEN, ANTISERUM, CONTROL (DBF) (2) RADIOIMMUNOASSAY, LUTEINIZING HORMONE (CEP) (2)

Premarket Exempt

No Yes

Clear

ARCHITECT - 00380740002091 Catalog Number : 01P7402

Device Description : ARCHITECT Folate Calibrators

Device Class : 1

Duns Number: 989964119

Premarket Exempt : No

Product Code : JJX, JIT, CGN

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740002114 Catalog Number : 01P7412

Device Description : ARCHITECT Folate Controls

Device Class : 1

Duns Number: 989964119

Premarket Exempt : No

Product Code : JIT, JJX, CGN

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740002138 Catalog Number : 01P7427

Device Description : ARCHITECT Folate Reagent Kit (100T)

Device Class : 1

Duns Number: 989964119

Premarket Exempt : No

Product Code : JIT, JJX, CGN

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740002152 Catalog Number : 01P7437

Device Description : ARCHITECT Folate Reagent Kit (500T)

Device Class : 1

Duns Number: 989964119

Premarket Exempt : No

Product Code : CGN, JIT, JJX

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740002176 Catalog Number : 01P7450

Device Description : ARCHITECT Folate Manual Diluent

Device Class : 1

Duns Number: 989964119

Premarket Exempt : No

Product Code : JJX, CGN, JIT

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003913 Catalog Number : 02P4001

Device Description : ARCHITECT LH Calibrators

Device Class : 2

Duns Number: 989964119

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003920 Catalog Number : 02P4025

Device Description : ARCHITECT LH Reagent Kit (100T)

Device Class : 1

Duns Number: 989964119

Premarket Exempt : Yes

Product Code : CEP

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003937 Catalog Number : 02P4035

Device Description : ARCHITECT LH Reagent Kit (500T)

Device Class : 1

Duns Number: 989964119

Premarket Exempt : Yes

Product Code : CEP

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740014070 Catalog Number : 07K5901

Device Description : ARCHITECT Ferritin Calibrators

Device Class : 2

Duns Number: 989964119

Premarket Exempt : No

Product Code : DBF

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740014087 Catalog Number : 07K5910

Device Description : ARCHITECT Ferritin Controls

Device Class : 2

Duns Number: 989964119

Premarket Exempt : No

Product Code : DBF

Prescription Use : Yes

Device Count : 1

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