Abbott GmbH

Address:Max-Planck-Ring 2,Wiesbaden Hesse,DE

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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

SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) (JJX) (7) CALIBRATOR, SECONDARY (JIT) (7) RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE (CDZ) (3) CALIBRATOR, PRIMARY (JIS) (2) RADIOIMMUNOASSAY, PARATHYROID HORMONE (CEW) (2) KIT, SEROLOGICAL, POSITIVE CONTROL (MJX) (2) Hepatitis a test (antibody and igm antibody) (LOL) (2) KIT, SEROLOGICAL, NEGATIVE CONTROL (MJY) (2) RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE) (JKC) (1)

Premarket Exempt

No Yes

Clear

ARCHITECT - 00380740011178 Catalog Number : 06L2710

Device Description : ARCHITECT HAVAB-G Controls

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : MJY, LOL, MJX, JIS

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740011185 Catalog Number : 06L2725

Device Description : ARCHITECT HAVAB-G Reagent Kit

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : MJY, JIS, LOL, MJX

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740017347 Catalog Number : 08K2501

Device Description : ARCHITECT Intact PTH Calibrators

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : CEW, JIT, JJX

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740017354 Catalog Number : 08K2510

Device Description : ARCHITECT Intact PTH Controls

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : CEW, JJX, JIT

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740017385 Catalog Number : 08K2601

Device Description : ARCHITECT SHBG Calibrators

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JIT, JJX, CDZ

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740017392 Catalog Number : 08K2610

Device Description : ARCHITECT SHBG Controls

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JIT, JJX, CDZ

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740017415 Catalog Number : 08K2625

Device Description : ARCHITECT SHBG Reagent Kit

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJX, JIT, CDZ

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740017422 Catalog Number : 08K2701

Device Description : ARCHITECT DHEA-S Calibrators

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJX, JIT

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740017439 Catalog Number : 08K2710

Device Description : ARCHITECT DHEA-S Controls

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JIT, JJX

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740017453 Catalog Number : 08K2725

Device Description : ARCHITECT DHEA-S Reagent Kit

Device Class : 1

Duns Number: 315786293

Premarket Exempt : Yes

Product Code : JKC

Prescription Use : Yes

Device Count : 1

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