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) (4) SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN (DHA) (4) SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) (JJX) (3) RADIOIMMUNOASSAY, FREE THYROXINE (CEC) (2) RADIOIMMUNOASSAY, PROGESTERONE (JLS) (2)

Premarket Exempt

No Yes

Clear

ARCHITECT - 00380740014889 Catalog Number : 07K7701

Device Description : ARCHITECT Progesterone Calibrators

Device Class : 2

Duns Number: 989964119

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740014896 Catalog Number : 07K7710

Device Description : ARCHITECT Progesterone Controls

Device Class : 1

Duns Number: 989964119

Premarket Exempt : No

Product Code : JIT, JJX

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740014919 Catalog Number : 07K7725

Device Description : ARCHITECT Progesterone Reagent Kit (100T)

Device Class : 1

Duns Number: 989964119

Premarket Exempt : Yes

Product Code : JLS

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740014926 Catalog Number : 07K7750

Device Description : ARCHITECT Progesterone Manual Diluent

Device Class : 1

Duns Number: 989964119

Premarket Exempt : Yes

Product Code : JLS

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740014933 Catalog Number : 07K7801

Device Description : ARCHITECT Total Beta hCG Calibrators

Device Class : 2

Duns Number: 989964119

Premarket Exempt : No

Product Code : DHA

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740014940 Catalog Number : 07K7810

Device Description : ARCHITECT Total Beta hCG Controls

Device Class : 2

Duns Number: 989964119

Premarket Exempt : No

Product Code : DHA

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740014964 Catalog Number : 07K7825

Device Description : ARCHITECT Total Beta hCG Reagent Kit (100T)

Device Class : 2

Duns Number: 989964119

Premarket Exempt : No

Product Code : DHA

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740014971 Catalog Number : 07K7830

Device Description : ARCHITECT Total Beta hCG Reagent Kit (2000T)

Device Class : 2

Duns Number: 989964119

Premarket Exempt : No

Product Code : DHA

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740081034 Catalog Number : 07K6502

Device Description : ARCHITECT Free T4 Calibrators

Device Class : 1

Duns Number: 989964119

Premarket Exempt : No

Product Code : JJX, JIT, CEC

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740081065 Catalog Number : 07K6532

Device Description : ARCHITECT Free T4 Reagent Kit (2000T)

Device Class : 1

Duns Number: 989964119

Premarket Exempt : No

Product Code : JJX, CEC, JIT

Prescription Use : Yes

Device Count : 1

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