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) SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) (JJX) (6) RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE (CDP) (2) RADIOIMMUNOASSAY, FREE THYROXINE (CEC) (2) RADIOIMMUNOASSAY, PROGESTERONE (JLS) (1) RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) (CFT) (1) RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE (JLW) (1) FERRITIN, ANTIGEN, ANTISERUM, CONTROL (DBF) (1) Enzyme immunoassay, non-radiolabeled, total thyroxine (KLI) (1) RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE (CGJ) (1)

Premarket Exempt

Yes No

Clear

ARCHITECT - 00380740081126 Catalog Number : 07K6527

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

Device Class : 1

Duns Number: 989964119

Premarket Exempt : No

Product Code : JJX, CEC, JIT

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740105921 Catalog Number : 07K6335

Device Description : ARCHITECT Free T3 Reagent Kit (500T)

Device Class : 1

Duns Number: 989964119

Premarket Exempt : No

Product Code : CDP, JIT, JJX

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740105938 Catalog Number : 07K6535

Device Description : ARCHITECT Free T4 Reagent Kit (500T)

Device Class : 1

Duns Number: 989964119

Premarket Exempt : No

Product Code : JIT, JJX, CEC

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740105945 Catalog Number : 07K6435

Device Description : ARCHITECT Total T3 Reagent Kit (500T)

Device Class : 1

Duns Number: 989964119

Premarket Exempt : No

Product Code : JJX, JIT, CDP

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740105952 Catalog Number : 07K6635

Device Description : ARCHITECT Total T4 Reagent Kit (500T)

Device Class : 1

Duns Number: 989964119

Premarket Exempt : No

Product Code : JIT, JJX, KLI

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740105969 Catalog Number : 07K6235

Device Description : ARCHITECT TSH Reagent Kit (500T)

Device Class : 1

Duns Number: 989964119

Premarket Exempt : No

Product Code : JLW, JJX, JIT

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740105976 Catalog Number : 07K5935

Device Description : ARCHITECT Ferritin Reagent Kit (500T)

Device Class : 2

Duns Number: 989964119

Premarket Exempt : No

Product Code : DBF

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740105983 Catalog Number : 07K7535

Device Description : ARCHITECT FSH Reagent Kit (500T)

Device Class : 1

Duns Number: 989964119

Premarket Exempt : Yes

Product Code : CGJ

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740105990 Catalog Number : 07K7635

Device Description : ARCHITECT Prolactin Reagent Kit (500T)

Device Class : 1

Duns Number: 989964119

Premarket Exempt : Yes

Product Code : CFT

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740106058 Catalog Number : 07K7735

Device Description : ARCHITECT PROGESTERONE REAGENT KIT 1 x 500

Device Class : 1

Duns Number: 989964119

Premarket Exempt : Yes

Product Code : JLS

Prescription Use : Yes

Device Count : 1

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