Abbott GmbH

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

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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, MULTI-ANALYTE MIXTURE (JIX) (3) Multi-analyte controls, all kinds (assayed) (JJY) (3) ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) (NHX) (3) ENZYME IMMUNOASSAY, GENTAMICIN (LCD) (2) Test, hiv detection (MZF) (2) CALIBRATOR, SECONDARY (JIT) (2) CALIBRATORS, DRUG SPECIFIC (DLJ) (2) RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE (CDZ) (2) SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) (JJX) (2) ENZYME IMMUNOASSAY, CARBAMAZEPINE (KLT) (1) CALIBRATORS, DRUG MIXTURE (DKB) (1)

Premarket Exempt

Yes No

Clear

ARCHITECT - 00380740001735 Catalog Number : 01P3101

Device Description : ARCHITECT iGentamicin Calibrators

Device Class : 2

Duns Number: 315786293

Premarket Exempt : No

Product Code : LCD, DLJ

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740001742 Catalog Number : 01P3125

Device Description : ARCHITECT iGentamicin Reagent Kit

Device Class : 2

Duns Number: 315786293

Premarket Exempt : No

Product Code : LCD, DLJ

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740001834 Catalog Number : 01P3601

Device Description : ARCHITECT iCarbamazepine Calibrators

Device Class : 2

Duns Number: 315786293

Premarket Exempt : No

Product Code : DKB, KLT

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740002022 Catalog Number : 01P6501

Device Description : ARCHITECT Anti-CCP Calibrators

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : NHX, JIX, JJY

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740002039 Catalog Number : 01P6510

Device Description : ARCHITECT Anti-CCP Controls

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JIX, JJY, NHX

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740002046 Catalog Number : 01P6525

Device Description : ARCHITECT Anti-CCP Reagent Kit

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : NHX, JIX, JJY

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003708 Catalog Number : 02P1301

Device Description : ARCHITECT 2nd Generation Testosterone Calibrators

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJX, JIT, CDZ

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003715 Catalog Number : 02P1310

Device Description : ARCHITECT 2nd Generation Testosterone Controls

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JIT, JJX, CDZ

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003876 Catalog Number : 02P3601

Device Description : ARCHITECT HIV Ag/Ab Combo Calibrator

Device Class : 2

Duns Number: 315786293

Premarket Exempt : No

Product Code : MZF

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003883 Catalog Number : 02P3610

Device Description : ARCHITECT HIV Ag/Ab Combo Controls

Device Class : 2

Duns Number: 315786293

Premarket Exempt : No

Product Code : MZF

Prescription Use : Yes

Device Count : 1

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