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) (7) CLINICAL SAMPLE CONCENTRATOR (JJH) (1) Hepatitis Viral B DNA Detection (MKT) (1) Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence (NSD) (1)

Premarket Exempt

No Yes

Clear

UroVysion - 00884999002180 Catalog Number : 02J27-095

Device Description : UroVysion Bladder Cancer Kit

Device Class : 3

Duns Number: 878263359

Premarket Exempt : No

Product Code : NSD

Prescription Use : Yes

Device Count : 1

Vysis - 00884999002609 Catalog Number : 02N11-030

Device Description : Vysis LSI TERC (3q26) SpectrumGold Probe

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Vysis - 00884999002623 Catalog Number : 02N12-030

Device Description : Vysis LSI MYC (8q24) SpectrumRed Probe

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Vysis - 00884999002708 Catalog Number : 02N19-010

Device Description : Vysis LSI MAPT 17q21 SpectrumGreen Probe

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Vysis - 00884999002715 Catalog Number : 02N20-020

Device Description : Vysis LSI ERBB2 (17q12) SpectrumGreen Probe

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Vysis - 00884999002722 Catalog Number : 02N21-020

Device Description : Vysis LSI p16 (9p21) SpectrumRed Probe

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Vysis - 00884999002739 Catalog Number : 02N22-020

Device Description : Vysis LSI MYC (8q24) SpectrumAqua Probe

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Vysis - 00884999002746 Catalog Number : 02N23-020

Device Description : Vysis LSI ZNF217 SpectrumGold Probe

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

m2000 - 00884999002883 Catalog Number : 02N29-01

Device Description : Hood Assembly G-Series

Device Class : 1

Duns Number: 878263359

Premarket Exempt : No

Product Code : JJH

Prescription Use : Yes

Device Count : 1

RealTime - 00884999003057 Catalog Number : 2N40-70

Device Description : Abbott RealTime HBV Calibrator Kit

Device Class : 3

Duns Number: 878263359

Premarket Exempt : No

Product Code : MKT

Prescription Use : Yes

Device Count : 1

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