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) (10) SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) (JJX) (10) RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE (CDP) (5) Enzyme immunoassay, non-radiolabeled, total thyroxine (KLI) (4) RADIOIMMUNOASSAY, FREE THYROXINE (CEC) (1)

Premarket Exempt

No Yes

Clear

ARCHITECT - 00380740014261 Catalog Number : 07K6310

Device Description : ARCHITECT Free T3 Controls

Device Class : 1

Duns Number: 989964119

Premarket Exempt : No

Product Code : JIT, CDP, JJX

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740014285 Catalog Number : 07K6325

Device Description : ARCHITECT Free T3 Reagent Kit (100T)

Device Class : 1

Duns Number: 989964119

Premarket Exempt : No

Product Code : JIT, JJX, CDP

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740014308 Catalog Number : 07K6401

Device Description : ARCHITECT Total T3 Calibrators

Device Class : 1

Duns Number: 989964119

Premarket Exempt : No

Product Code : JIT, CDP, JJX

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740014322 Catalog Number : 07K6425

Device Description : ARCHITECT Total T3 Reagent Kit (100T)

Device Class : 1

Duns Number: 989964119

Premarket Exempt : No

Product Code : CDP, JJX, JIT

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740014346 Catalog Number : 07K6450

Device Description : ARCHITECT Total T3 Manual Diluent

Device Class : 1

Duns Number: 989964119

Premarket Exempt : No

Product Code : JIT, JJX, CDP

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740014360 Catalog Number : 07K6510

Device Description : ARCHITECT Free T4 Controls

Device Class : 1

Duns Number: 989964119

Premarket Exempt : No

Product Code : JJX, CEC, JIT

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740014407 Catalog Number : 07K6601

Device Description : ARCHITECT Total T4 Calibrators

Device Class : 1

Duns Number: 989964119

Premarket Exempt : No

Product Code : JJX, JIT, KLI

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740014414 Catalog Number : 07K6610

Device Description : ARCHITECT Total T4 Controls

Device Class : 1

Duns Number: 989964119

Premarket Exempt : No

Product Code : JJX, JIT, KLI

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740014438 Catalog Number : 07K6625

Device Description : ARCHITECT Total T4 Reagent Kit (100T)

Device Class : 1

Duns Number: 989964119

Premarket Exempt : No

Product Code : JJX, KLI, JIT

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740014445 Catalog Number : 07K6630

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

Device Class : 1

Duns Number: 989964119

Premarket Exempt : No

Product Code : KLI, JJX, JIT

Prescription Use : Yes

Device Count : 1

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