ABBOTT MOLECULAR INC.

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

General purpose reagent (PPM) (3) SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM (MVD) (3) CLINICAL SAMPLE CONCENTRATOR (JJH) (2) Dna-probe kit, human chromosome (OYU) (1) System, automated scanning microscope and image analysis for fluorescence in situ hybridization (fish) assays (NTH) (1)

Premarket Exempt

No Yes

Clear

m2000 - 00884999001350 Catalog Number : 01N94-01

Device Description : m2000 System 16mm PoSt Set

Device Class : 1

Duns Number: 878263359

Premarket Exempt : No

Product Code : JJH

Prescription Use : Yes

Device Count : 1

m2000 - 00884999001381 Catalog Number : 01N97-01

Device Description : m2000 System Pierceable Cap Sample Rack Set

Device Class : 1

Duns Number: 878263359

Premarket Exempt : No

Product Code : JJH

Prescription Use : Yes

Device Count : 1

Vysis - 00884999001404 Catalog Number : 01N99-001

Device Description : Protease Buffer II

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

PathVysion - 00884999001732 Catalog Number : 02J01-030

Device Description : PathVysion HER-2 DNA Probe Kit

Device Class : 3

Duns Number: 878263359

Premarket Exempt : No

Product Code : MVD

Prescription Use : Yes

Device Count : 1

PathVysion - 00884999001756 Catalog Number : 02J01-035

Device Description : PathVysion HER-2 DNA Probe Kit

Device Class : 3

Duns Number: 878263359

Premarket Exempt : No

Product Code : MVD

Prescription Use : Yes

Device Count : 1

PathVysion - 00884999001763 Catalog Number : 02J01-036

Device Description : PathVysion HER-2 DNA Probe Kit

Device Class : 3

Duns Number: 878263359

Premarket Exempt : No

Product Code : MVD

Prescription Use : Yes

Device Count : 1

Vysis - 00884999001800 Catalog Number : 02J02-032

Device Description : VYSIS Paraffin Pretreatment Reagent Kit

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

Vysis - 00884999001817 Catalog Number : 02J03-032

Device Description : Vysis FISH Pretreatment Reagent Kit

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

Vysis - 00884999001824 Catalog Number : 02J04-010

Device Description : ProbeChek PathVysion HER-2/neu Cut-Off Control Slides

Device Class : 2

Duns Number: 878263359

Premarket Exempt : No

Product Code : NTH

Prescription Use : Yes

Device Count : 1

PathVysion - 00884999001831 Catalog Number : 02J04-030

Device Description : ProbeChek PathVysion HER-2/neu Cut-Off Control Slides

Device Class : 2

Duns Number: 878263359

Premarket Exempt : No

Product Code : OYU

Prescription Use : Yes

Device Count : 1

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