ABBOTT MOLECULAR INC.

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

Want to know more about this Organization? Request more information now!

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

real time Nucleic acid amplification system (OOI) (4) Nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections (QEP) (2) Test, HIV detection (MZF) (2) Hepatitis Viral B DNA Detection (MKT) (1) STAINER, TISSUE, AUTOMATED (KEY) (1)

Premarket Exempt

No Yes

Clear

Alinity m - 00884999047907 Catalog Number : 09N20-003

Device Description : Alinity m Diluent Solution Kit

Device Class : 2

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : OOI

Prescription Use : Yes

Device Count : 1

Alinity m - 00884999048034 Catalog Number : 08N53-002

Device Description : Alinity m System

Device Class : 2

Duns Number: 878263359

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

RealTime - 00884999048065 Catalog Number : 06L83-008

Device Description : Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM

Device Class : 2

Duns Number: 878263359

Premarket Exempt : No

Product Code : MZF

Prescription Use : Yes

Device Count : 1

Alinity m - 00884999048096 Catalog Number : 09N26-019

Device Description : Alinity m Sample Rack Holder

Device Class : 2

Duns Number: 878263359

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

Alinity m - 00884999048171 Catalog Number : 09N26-020

Device Description : Alinity m IRU Waste Container

Device Class : 2

Duns Number: 878263359

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

VP2000 - 00884999048478 Catalog Number : 02J11-057

Device Description : VP 2000 System Software v2.1 with Protocols USB

Device Class : 1

Duns Number: 878263359

Premarket Exempt : Yes

Product Code : KEY

Prescription Use : No

Device Count : 1

Alinity m - 00884999048591 Catalog Number : 09N17-095

Device Description : Alinity m STI AMP Kit

Device Class : 2

Duns Number: 878263359

Premarket Exempt : No

Product Code : QEP

Prescription Use : No

Device Count : 1

Alinity m - 00884999048607 Catalog Number : 09N17-085

Device Description : Alinity m STI CTRL Kit

Device Class : 2

Duns Number: 878263359

Premarket Exempt : No

Product Code : QEP

Prescription Use : No

Device Count : 1

Alinity m - 00884999048638 Catalog Number : 08N45-03A

Device Description : Alinity m HIV-1 Application Specification File

Device Class : 2

Duns Number: 878263359

Premarket Exempt : No

Product Code : MZF

Prescription Use : No

Device Count : 1

Alinity m - 00884999048645 Catalog Number : 08N47-03A

Device Description : Alinity m HBV Application Specification File

Device Class : 3

Duns Number: 878263359

Premarket Exempt : No

Product Code : MKT

Prescription Use : No

Device Count : 1

Previous 1 … 43 44 45 … 48 Next