SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0450-027-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
Abbott RealTime HCV
Assay Type
NAT (nucleic acid testing)
IVD Public Report Category
HCV NAT
Regulatory Version Submitted To PQ
JMHLW: Minister’s approval
Applicant organization
Abbott Molecular Inc.
1300 East Touhy Avenue
Des Plaines,
60018
United States of America
Pathogen
HCV
Specimen Type
Plasma
Serum
Product Code
Identification name
4J86-70
Test Package Size
4J86-90 Amplification reagent kit
4 packs of 4J86 - 24 tests/pack
internal control 4J86Y - 4 vials
4J86-80 control kit
negative control
high positive control
low positive control
4J86-70 calibrator kit
cal A
cal B
4 packs of 4J86 - 24 tests/pack
internal control 4J86Y - 4 vials
4J86-80 control kit
negative control
high positive control
low positive control
4J86-70 calibrator kit
cal A
cal B
Identification name
4J86-80
Test Package Size
4J86-90 Amplification reagent kit
4 packs of 4J86 - 24 tests/pack
internal control 4J86Y - 4 vials
4J86-80 control kit
negative control
high positive control
low positive control
4J86-70 calibrator kit
cal A
cal B
4 packs of 4J86 - 24 tests/pack
internal control 4J86Y - 4 vials
4J86-80 control kit
negative control
high positive control
low positive control
4J86-70 calibrator kit
cal A
cal B
Identification name
4J86-90
Test kit package size
24
Test Package Size
4J86-90 Amplification reagent kit
4 packs of 4J86 - 24 tests/pack
internal control 4J86Y - 4 vials
4J86-80 control kit
negative control
high positive control
low positive control
4J86-70 calibrator kit
cal A
cal B
4 packs of 4J86 - 24 tests/pack
internal control 4J86Y - 4 vials
4J86-80 control kit
negative control
high positive control
low positive control
4J86-70 calibrator kit
cal A
cal B
IVD Manufacturing Site(s)
Abbott Molecular Inc.
1300 East Touhy Avenue
Des Plaines,
60018
United States of America