ABBOTT LABORATORIES

Address:Conway Park,Lake Forest,IL,60045,US

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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) TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125) (LTK) (5) SYSTEM, TEST, THYROID AUTOANTIBODY (JZO) (4) SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR (MOI) (1)

Premarket Exempt

No Yes

Clear

ARCHITECT - 00380740003357 Catalog Number : 02K4435

Device Description : ARCHITECT CA15-3 Reagent Kit

Device Class : 1

Duns Number: 079226220

Premarket Exempt : No

Product Code : JJX, MOI, JIT

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003364 Catalog Number : 02K4501

Device Description : ARCHITECT CA125 II Calibrators

Device Class : 1

Duns Number: 079226220

Premarket Exempt : No

Product Code : LTK, JJX, JIT

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003371 Catalog Number : 02K4510

Device Description : ARCHITECT CA125 II Controls

Device Class : 1

Duns Number: 079226220

Premarket Exempt : No

Product Code : LTK, JIT, JJX

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003388 Catalog Number : 02K4520

Device Description : ARCHITECT CA125 II Reagent Kit

Device Class : 1

Duns Number: 079226220

Premarket Exempt : No

Product Code : LTK, JIT, JJX

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003395 Catalog Number : 02K4525

Device Description : ARCHITECT CA125 II Reagent Kit

Device Class : 1

Duns Number: 079226220

Premarket Exempt : No

Product Code : JJX, JIT, LTK

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003401 Catalog Number : 02K4535

Device Description : ARCHITECT CA125 II Reagent Kit

Device Class : 1

Duns Number: 079226220

Premarket Exempt : No

Product Code : JJX, LTK, JIT

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003418 Catalog Number : 02K4601

Device Description : ARCHITECT Anti-Tg Calibrators

Device Class : 1

Duns Number: 079226220

Premarket Exempt : No

Product Code : JJX, JIT, JZO

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003425 Catalog Number : 02K4610

Device Description : ARCHITECT Anti-Tg Controls

Device Class : 1

Duns Number: 079226220

Premarket Exempt : No

Product Code : JIT, JJX, JZO

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003432 Catalog Number : 02K4620

Device Description : ARCHITECT Anti-Tg Reagent Kit

Device Class : 1

Duns Number: 079226220

Premarket Exempt : No

Product Code : JZO, JJX, JIT

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003449 Catalog Number : 02K4625

Device Description : ARCHITECT Anti-Tg Reagent Kit

Device Class : 1

Duns Number: 079226220

Premarket Exempt : No

Product Code : JIT, JJX, JZO

Prescription Use : Yes

Device Count : 1

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