ABBOTT LABORATORIES

Address:U.S. 41/MARTIN LUTHER KING DR.,North Chicago,IL,60064,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, PRIMARY (JIS) (5) SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) (JJX) (4) CALIBRATOR, SECONDARY (JIT) (4) SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR (MOI) (4) MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL (DDR) (3) FLUOROMETRIC METHOD, CPK OR ISOENZYMES (JHX) (2) Multi-analyte controls, all kinds (assayed) (JJY) (1)

Premarket Exempt

No Yes

Clear

ARCHITECT - 00380740003258 Catalog Number : 02K4225

Device Description : ARCHITECT STAT CK-MB Reagent Kit

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : JIS, JHX

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003265 Catalog Number : 02K4235

Device Description : ARCHITECT STAT CK-MB Reagent Kit

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : JHX, JIS

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003272 Catalog Number : 02K4301

Device Description : ARCHITECT STAT Myoglobin Calibrators

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : JIS, DDR

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003289 Catalog Number : 02K4310

Device Description : ARCHITECT STAT Myoglobin Controls

Device Class : 1

Duns Number: 079226220

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003296 Catalog Number : 02K4320

Device Description : ARCHITECT STAT Myoglobin Reagent Kit

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : DDR, JIS

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003302 Catalog Number : 02K4325

Device Description : ARCHITECT STAT Myoglobin Reagent Kit

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : JIS, DDR

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003319 Catalog Number : 02K4401

Device Description : ARCHITECT CA15-3 Calibrators

Device Class : 1

Duns Number: 079226220

Premarket Exempt : No

Product Code : JIT, MOI, JJX

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003326 Catalog Number : 02K4410

Device Description : ARCHITECT CA15-3 Controls

Device Class : 1

Duns Number: 079226220

Premarket Exempt : No

Product Code : JIT, MOI, JJX

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003333 Catalog Number : 02K4420

Device Description : ARCHITECT CA15-3 Reagent Kit

Device Class : 1

Duns Number: 079226220

Premarket Exempt : No

Product Code : JJX, JIT, MOI

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003340 Catalog Number : 02K4425

Device Description : ARCHITECT CA15-3 Reagent Kit

Device Class : 1

Duns Number: 079226220

Premarket Exempt : No

Product Code : JJX, JIT, MOI

Prescription Use : Yes

Device Count : 1

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