ABBOTT MOLECULAR INC.

Address:1300 EAST TOUHY AVENUE,Des Plaines,IL,60018,US

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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

REAGENTS,SPECIFIC,ANALYTE (MVU) (4) ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS (MZP) (3) CLINICAL SAMPLE CONCENTRATOR (JJH) (2) Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement (OWE) (1)

Premarket Exempt

No Yes

Clear

RealTime - 00884999000704 Catalog Number : 1N30-70

Device Description : Abbott RealTime HCV Calibrator Kit

Device Class : 2

Duns Number: 878263359

Premarket Exempt : No

Product Code : MZP

Prescription Use : Yes

Device Count : 1

RealTime - 00884999000711 Catalog Number : 1N30-80

Device Description : Abbott RealTime HCV Control Kit

Device Class : 2

Duns Number: 878263359

Premarket Exempt : No

Product Code : MZP

Prescription Use : Yes

Device Count : 1

RealTime - 00884999000728 Catalog Number : 1N30-90

Device Description : Abbott RealTime HCV Amplification Reagent Kit

Device Class : 2

Duns Number: 878263359

Premarket Exempt : No

Product Code : MZP

Prescription Use : Yes

Device Count : 1

Vysis - 00884999000735 Catalog Number : 01N31-005

Device Description : Vysis Paraffin Pretreatment IV & Post-Hybridization Wash Buffer Kit

Device Class : 3

Duns Number: 878263359

Premarket Exempt : No

Product Code : OWE

Prescription Use : Yes

Device Count : 1

Vysis - 00884999000810 Catalog Number : 01N61-001

Device Description : Vysis LSI Xq13.2 (XIST) SO Probe

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Vysis - 00884999001015 Catalog Number : 01N78-020

Device Description : Vysis LSI TRA/D Dual Color Break Apart Rearrangement Probes

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Vysis - 00884999001039 Catalog Number : 01N79-020

Device Description : Vysis LSI 4q12 Tricolor Rearrangement Probe

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Vysis - 00884999001305 Catalog Number : 01N88-030

Device Description : Vysis LSI CCND1 SpectrumGreen Probe

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

m2000 - 00884999001336 Catalog Number : 01N92-02

Device Description : m2000 System Pierceable Cap Sample Rack PoSt Set

Device Class : 1

Duns Number: 878263359

Premarket Exempt : No

Product Code : JJH

Prescription Use : Yes

Device Count : 1

m2000 - 00884999001343 Catalog Number : 01N93-01

Device Description : m2000 System 13mm PoSt Set

Device Class : 1

Duns Number: 878263359

Premarket Exempt : No

Product Code : JJH

Prescription Use : Yes

Device Count : 1

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