Abbott Ireland Diagnostics

Address:Lisnamuck,Longford,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

Test, hepatitis b (b core, be antigen, be antibody, b core igm) (LOM) (9) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE (JJE) (1)

Premarket Exempt

No Yes

Clear

ARCHITECT - 00380740001193 Catalog Number : 01L5640

Device Description : ARCHITECT Probe Conditioning Solution

Device Class : 1

Duns Number: 985307301

Premarket Exempt : Yes

Product Code : JJE

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740001490 Catalog Number : 01L8202

Device Description : ARCHITECT AUSAB Calibrators

Device Class : 3

Duns Number: 985307301

Premarket Exempt : No

Product Code : LOM

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740001506 Catalog Number : 01L8212

Device Description : ARCHITECT AUSAB Controls

Device Class : 3

Duns Number: 985307301

Premarket Exempt : No

Product Code : LOM

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740001513 Catalog Number : 01L8225

Device Description : ARCHITECT AUSAB Reagent Kit

Device Class : 3

Duns Number: 985307301

Premarket Exempt : No

Product Code : LOM

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740001520 Catalog Number : 01L8235

Device Description : ARCHITECT AUSAB Reagent Kit

Device Class : 3

Duns Number: 985307301

Premarket Exempt : No

Product Code : LOM

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740007751 Catalog Number : 04P5301

Device Description : ARCHITECT HBsAg Qualitative Calibrators

Device Class : 3

Duns Number: 985307301

Premarket Exempt : No

Product Code : LOM

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740007768 Catalog Number : 04P5310

Device Description : ARCHITECT HBsAg Qualitative Controls

Device Class : 3

Duns Number: 985307301

Premarket Exempt : No

Product Code : LOM

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740007775 Catalog Number : 04P5325

Device Description : ARCHITECT HBsAg Qualitative Reagent Kit

Device Class : 3

Duns Number: 985307301

Premarket Exempt : No

Product Code : LOM

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740007782 Catalog Number : 04P5335

Device Description : ARCHITECT HBsAg Qualitative Reagent Kit

Device Class : 3

Duns Number: 985307301

Premarket Exempt : No

Product Code : LOM

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740007799 Catalog Number : 04P5425

Device Description : ARCHITECT HBsAg Qualitative Confirmatory Reagent Kit

Device Class : 3

Duns Number: 985307301

Premarket Exempt : No

Product Code : LOM

Prescription Use : Yes

Device Count : 1

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