SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0084-027-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Abbott RealTime HIV-1 Qualitative (m2000sp)
Assay Type
NAT (nucleic acid testing)
IVD Public Report Category
HIV NAT
Regulatory Version Submitted To PQ
Directive 98/79/EC: Product design examination certificate, Annex IV.4
Applicant organization
Abbott Molecular Inc.
1300 East Touhy Avenue
Des Plaines,
60018
United States of America
Pathogen
HIV
Specimen Type
Plasma
Whole blood (dried blood spot)
Product Code
Identification name
4N66-01
Test Package Size
Instrumentation:
Abbott m2000sp Instrument 9K14-02
Abbott m2000rt Instrument 9K15-01
Reagents:
Abbott mSample Preparation SystemDNA 6K12-24
Abbott RealTime HIV-1 Qualitative Amplification Reagent Kit 4N66-90
Abbott RealTime HIV-1 Qualitative Control Kit 4N66-80
Software:
Abbott RealTime HIV‑1 Qualitative m2000 System Combined Application CD‑ROM 4N66-01 or higher
Optional:
Abbott RealTime HIV-1 UNG Protocol 4N66-66
Consumables required:
Abbott m2000rt Optical Calibration kit 4J71-93
5 mL Reaction Vessels (List No
Abbott m2000sp Instrument 9K14-02
Abbott m2000rt Instrument 9K15-01
Reagents:
Abbott mSample Preparation SystemDNA 6K12-24
Abbott RealTime HIV-1 Qualitative Amplification Reagent Kit 4N66-90
Abbott RealTime HIV-1 Qualitative Control Kit 4N66-80
Software:
Abbott RealTime HIV‑1 Qualitative m2000 System Combined Application CD‑ROM 4N66-01 or higher
Optional:
Abbott RealTime HIV-1 UNG Protocol 4N66-66
Consumables required:
Abbott m2000rt Optical Calibration kit 4J71-93
5 mL Reaction Vessels (List No
Identification name
4N66-66
Test Package Size
Instrumentation:
Abbott m2000sp Instrument 9K14-02
Abbott m2000rt Instrument 9K15-01
Reagents:
Abbott mSample Preparation SystemDNA 6K12-24
Abbott RealTime HIV-1 Qualitative Amplification Reagent Kit 4N66-90
Abbott RealTime HIV-1 Qualitative Control Kit 4N66-80
Software:
Abbott RealTime HIV‑1 Qualitative m2000 System Combined Application CD‑ROM 4N66-01 or higher
Optional:
Abbott RealTime HIV-1 UNG Protocol 4N66-66
Consumables required:
Abbott m2000rt Optical Calibration kit 4J71-93
5 mL Reaction Vessels (List No
Abbott m2000sp Instrument 9K14-02
Abbott m2000rt Instrument 9K15-01
Reagents:
Abbott mSample Preparation SystemDNA 6K12-24
Abbott RealTime HIV-1 Qualitative Amplification Reagent Kit 4N66-90
Abbott RealTime HIV-1 Qualitative Control Kit 4N66-80
Software:
Abbott RealTime HIV‑1 Qualitative m2000 System Combined Application CD‑ROM 4N66-01 or higher
Optional:
Abbott RealTime HIV-1 UNG Protocol 4N66-66
Consumables required:
Abbott m2000rt Optical Calibration kit 4J71-93
5 mL Reaction Vessels (List No
Identification name
4N66-80
Test Package Size
Instrumentation:
Abbott m2000sp Instrument 9K14-02
Abbott m2000rt Instrument 9K15-01
Reagents:
Abbott mSample Preparation SystemDNA 6K12-24
Abbott RealTime HIV-1 Qualitative Amplification Reagent Kit 4N66-90
Abbott RealTime HIV-1 Qualitative Control Kit 4N66-80
Software:
Abbott RealTime HIV‑1 Qualitative m2000 System Combined Application CD‑ROM 4N66-01 or higher
Optional:
Abbott RealTime HIV-1 UNG Protocol 4N66-66
Consumables required:
Abbott m2000rt Optical Calibration kit 4J71-93
5 mL Reaction Vessels (List No
Abbott m2000sp Instrument 9K14-02
Abbott m2000rt Instrument 9K15-01
Reagents:
Abbott mSample Preparation SystemDNA 6K12-24
Abbott RealTime HIV-1 Qualitative Amplification Reagent Kit 4N66-90
Abbott RealTime HIV-1 Qualitative Control Kit 4N66-80
Software:
Abbott RealTime HIV‑1 Qualitative m2000 System Combined Application CD‑ROM 4N66-01 or higher
Optional:
Abbott RealTime HIV-1 UNG Protocol 4N66-66
Consumables required:
Abbott m2000rt Optical Calibration kit 4J71-93
5 mL Reaction Vessels (List No
Identification name
4N66-90
Test Package Size
Instrumentation:
Abbott m2000sp Instrument 9K14-02
Abbott m2000rt Instrument 9K15-01
Reagents:
Abbott mSample Preparation SystemDNA 6K12-24
Abbott RealTime HIV-1 Qualitative Amplification Reagent Kit 4N66-90
Abbott RealTime HIV-1 Qualitative Control Kit 4N66-80
Software:
Abbott RealTime HIV‑1 Qualitative m2000 System Combined Application CD‑ROM 4N66-01 or higher
Optional:
Abbott RealTime HIV-1 UNG Protocol 4N66-66
Consumables required:
Abbott m2000rt Optical Calibration kit 4J71-93
5 mL Reaction Vessels (List No
Abbott m2000sp Instrument 9K14-02
Abbott m2000rt Instrument 9K15-01
Reagents:
Abbott mSample Preparation SystemDNA 6K12-24
Abbott RealTime HIV-1 Qualitative Amplification Reagent Kit 4N66-90
Abbott RealTime HIV-1 Qualitative Control Kit 4N66-80
Software:
Abbott RealTime HIV‑1 Qualitative m2000 System Combined Application CD‑ROM 4N66-01 or higher
Optional:
Abbott RealTime HIV-1 UNG Protocol 4N66-66
Consumables required:
Abbott m2000rt Optical Calibration kit 4J71-93
5 mL Reaction Vessels (List No
Identification name
6K12-24
Test Package Size
Instrumentation:
Abbott m2000sp Instrument 9K14-02
Abbott m2000rt Instrument 9K15-01
Reagents:
Abbott mSample Preparation SystemDNA 6K12-24
Abbott RealTime HIV-1 Qualitative Amplification Reagent Kit 4N66-90
Abbott RealTime HIV-1 Qualitative Control Kit 4N66-80
Software:
Abbott RealTime HIV‑1 Qualitative m2000 System Combined Application CD‑ROM 4N66-01 or higher
Optional:
Abbott RealTime HIV-1 UNG Protocol 4N66-66
Consumables required:
Abbott m2000rt Optical Calibration kit 4J71-93
5 mL Reaction Vessels (List No
Abbott m2000sp Instrument 9K14-02
Abbott m2000rt Instrument 9K15-01
Reagents:
Abbott mSample Preparation SystemDNA 6K12-24
Abbott RealTime HIV-1 Qualitative Amplification Reagent Kit 4N66-90
Abbott RealTime HIV-1 Qualitative Control Kit 4N66-80
Software:
Abbott RealTime HIV‑1 Qualitative m2000 System Combined Application CD‑ROM 4N66-01 or higher
Optional:
Abbott RealTime HIV-1 UNG Protocol 4N66-66
Consumables required:
Abbott m2000rt Optical Calibration kit 4J71-93
5 mL Reaction Vessels (List No
Identification name
9K14-02
Test Package Size
Instrumentation:
Abbott m2000sp Instrument 9K14-02
Abbott m2000rt Instrument 9K15-01
Reagents:
Abbott mSample Preparation SystemDNA 6K12-24
Abbott RealTime HIV-1 Qualitative Amplification Reagent Kit 4N66-90
Abbott RealTime HIV-1 Qualitative Control Kit 4N66-80
Software:
Abbott RealTime HIV‑1 Qualitative m2000 System Combined Application CD‑ROM 4N66-01 or higher
Optional:
Abbott RealTime HIV-1 UNG Protocol 4N66-66
Consumables required:
Abbott m2000rt Optical Calibration kit 4J71-93
5 mL Reaction Vessels (List No
Abbott m2000sp Instrument 9K14-02
Abbott m2000rt Instrument 9K15-01
Reagents:
Abbott mSample Preparation SystemDNA 6K12-24
Abbott RealTime HIV-1 Qualitative Amplification Reagent Kit 4N66-90
Abbott RealTime HIV-1 Qualitative Control Kit 4N66-80
Software:
Abbott RealTime HIV‑1 Qualitative m2000 System Combined Application CD‑ROM 4N66-01 or higher
Optional:
Abbott RealTime HIV-1 UNG Protocol 4N66-66
Consumables required:
Abbott m2000rt Optical Calibration kit 4J71-93
5 mL Reaction Vessels (List No
Identification name
9K15-01
Test Package Size
Instrumentation:
Abbott m2000sp Instrument 9K14-02
Abbott m2000rt Instrument 9K15-01
Reagents:
Abbott mSample Preparation SystemDNA 6K12-24
Abbott RealTime HIV-1 Qualitative Amplification Reagent Kit 4N66-90
Abbott RealTime HIV-1 Qualitative Control Kit 4N66-80
Software:
Abbott RealTime HIV‑1 Qualitative m2000 System Combined Application CD‑ROM 4N66-01 or higher
Optional:
Abbott RealTime HIV-1 UNG Protocol 4N66-66
Consumables required:
Abbott m2000rt Optical Calibration kit 4J71-93
5 mL Reaction Vessels (List No
Abbott m2000sp Instrument 9K14-02
Abbott m2000rt Instrument 9K15-01
Reagents:
Abbott mSample Preparation SystemDNA 6K12-24
Abbott RealTime HIV-1 Qualitative Amplification Reagent Kit 4N66-90
Abbott RealTime HIV-1 Qualitative Control Kit 4N66-80
Software:
Abbott RealTime HIV‑1 Qualitative m2000 System Combined Application CD‑ROM 4N66-01 or higher
Optional:
Abbott RealTime HIV-1 UNG Protocol 4N66-66
Consumables required:
Abbott m2000rt Optical Calibration kit 4J71-93
5 mL Reaction Vessels (List No
IVD Manufacturing Site(s)
Abbott Molecular Inc.
1300 East Touhy Avenue
Des Plaines,
60018
United States of America