SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0083-027-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Abbott RealTime HIV-1 (m24sp)
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
Product Code
Identification name
2G31-70
Test Package Size
Instrumentation:
Abbott m24sp Instrument 3N06-01
Abbott m2000rt Instrument 9K15-01
Reagents:
m Sample Preparation SystemRNA (4 X 24 Preps) 04J70-24
Abbott RealTime HIV-1 2G31 list which includes the following kits:
- Abbott RealTime HIV-1 Amplification Reagent Kit (2G31-90),
- Abbott RealTime HIV-1 Control Kit (2G31-80)
- Abbott RealTime HIV-1 Calibrator Kit (2G31-70)
Abbott m2000rt Optical Calibration kit 4J71-93
Software:
Abbott RealTime HIV-1 m2000 ROW System Combined Application CD-ROM 1L68-09 or
higher
Abbott m24sp Instrument 3N06-01
Abbott m2000rt Instrument 9K15-01
Reagents:
m Sample Preparation SystemRNA (4 X 24 Preps) 04J70-24
Abbott RealTime HIV-1 2G31 list which includes the following kits:
- Abbott RealTime HIV-1 Amplification Reagent Kit (2G31-90),
- Abbott RealTime HIV-1 Control Kit (2G31-80)
- Abbott RealTime HIV-1 Calibrator Kit (2G31-70)
Abbott m2000rt Optical Calibration kit 4J71-93
Software:
Abbott RealTime HIV-1 m2000 ROW System Combined Application CD-ROM 1L68-09 or
higher
Identification name
2G31-80
Test Package Size
Instrumentation:
Abbott m24sp Instrument 3N06-01
Abbott m2000rt Instrument 9K15-01
Reagents:
m Sample Preparation SystemRNA (4 X 24 Preps) 04J70-24
Abbott RealTime HIV-1 2G31 list which includes the following kits:
- Abbott RealTime HIV-1 Amplification Reagent Kit (2G31-90),
- Abbott RealTime HIV-1 Control Kit (2G31-80)
- Abbott RealTime HIV-1 Calibrator Kit (2G31-70)
Abbott m2000rt Optical Calibration kit 4J71-93
Software:
Abbott RealTime HIV-1 m2000 ROW System Combined Application CD-ROM 1L68-09 or
higher
Abbott m24sp Instrument 3N06-01
Abbott m2000rt Instrument 9K15-01
Reagents:
m Sample Preparation SystemRNA (4 X 24 Preps) 04J70-24
Abbott RealTime HIV-1 2G31 list which includes the following kits:
- Abbott RealTime HIV-1 Amplification Reagent Kit (2G31-90),
- Abbott RealTime HIV-1 Control Kit (2G31-80)
- Abbott RealTime HIV-1 Calibrator Kit (2G31-70)
Abbott m2000rt Optical Calibration kit 4J71-93
Software:
Abbott RealTime HIV-1 m2000 ROW System Combined Application CD-ROM 1L68-09 or
higher
Identification name
2G31-90
Test Package Size
Instrumentation:
Abbott m24sp Instrument 3N06-01
Abbott m2000rt Instrument 9K15-01
Reagents:
m Sample Preparation SystemRNA (4 X 24 Preps) 04J70-24
Abbott RealTime HIV-1 2G31 list which includes the following kits:
- Abbott RealTime HIV-1 Amplification Reagent Kit (2G31-90),
- Abbott RealTime HIV-1 Control Kit (2G31-80)
- Abbott RealTime HIV-1 Calibrator Kit (2G31-70)
Abbott m2000rt Optical Calibration kit 4J71-93
Software:
Abbott RealTime HIV-1 m2000 ROW System Combined Application CD-ROM 1L68-09 or
higher
Abbott m24sp Instrument 3N06-01
Abbott m2000rt Instrument 9K15-01
Reagents:
m Sample Preparation SystemRNA (4 X 24 Preps) 04J70-24
Abbott RealTime HIV-1 2G31 list which includes the following kits:
- Abbott RealTime HIV-1 Amplification Reagent Kit (2G31-90),
- Abbott RealTime HIV-1 Control Kit (2G31-80)
- Abbott RealTime HIV-1 Calibrator Kit (2G31-70)
Abbott m2000rt Optical Calibration kit 4J71-93
Software:
Abbott RealTime HIV-1 m2000 ROW System Combined Application CD-ROM 1L68-09 or
higher
IVD Manufacturing Site(s)
Abbott Molecular Inc.
1300 East Touhy Avenue
Des Plaines,
60018
United States of America