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0468-046-00

SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0468-046-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
cobas HPV
Assay Type
NAT (nucleic acid testing)
IVD Public Report Category
HPV NAT
Regulatory Version Submitted To PQ
JMHLW: Minister’s approval
Applicant organization
Roche Molecular Systems, Inc.
4300 Hacienda Drive, CA
Branchburg Township,
8876
United States of America
Pathogen
HPV
Specimen Type
Swab (cervicovaginal)
Product Code
Identification name
6997503190
Test Package Size
Cobas HPV 07460155190, 480 tests/kit
cobas® HPV Positive Control Kit, 07460171190, 16ml
HPV Negative Control Kit, 07002238190 , 16ml

cobas omni MGP Reagent, 06997546190, 480 tests
cobas omni Specimen Diluent , 06997511190, 4 x 875 ml
cobas omni Lysis Reagent, 06997538190, 4 x 875 ml
cobas omni Wash Reagent, 06997503190, 4
Identification name
6997511190
Test Package Size
Cobas HPV 07460155190, 480 tests/kit
cobas® HPV Positive Control Kit, 07460171190, 16ml
HPV Negative Control Kit, 07002238190 , 16ml

cobas omni MGP Reagent, 06997546190, 480 tests
cobas omni Specimen Diluent , 06997511190, 4 x 875 ml
cobas omni Lysis Reagent, 06997538190, 4 x 875 ml
cobas omni Wash Reagent, 06997503190, 4
Identification name
6997538190
Test Package Size
Cobas HPV 07460155190, 480 tests/kit
cobas® HPV Positive Control Kit, 07460171190, 16ml
HPV Negative Control Kit, 07002238190 , 16ml

cobas omni MGP Reagent, 06997546190, 480 tests
cobas omni Specimen Diluent , 06997511190, 4 x 875 ml
cobas omni Lysis Reagent, 06997538190, 4 x 875 ml
cobas omni Wash Reagent, 06997503190, 4
Identification name
6997546190
Test Package Size
Cobas HPV 07460155190, 480 tests/kit
cobas® HPV Positive Control Kit, 07460171190, 16ml
HPV Negative Control Kit, 07002238190 , 16ml

cobas omni MGP Reagent, 06997546190, 480 tests
cobas omni Specimen Diluent , 06997511190, 4 x 875 ml
cobas omni Lysis Reagent, 06997538190, 4 x 875 ml
cobas omni Wash Reagent, 06997503190, 4
Identification name
7002238190
Test Package Size
Cobas HPV 07460155190, 480 tests/kit
cobas® HPV Positive Control Kit, 07460171190, 16ml
HPV Negative Control Kit, 07002238190 , 16ml

cobas omni MGP Reagent, 06997546190, 480 tests
cobas omni Specimen Diluent , 06997511190, 4 x 875 ml
cobas omni Lysis Reagent, 06997538190, 4 x 875 ml
cobas omni Wash Reagent, 06997503190, 4
Identification name
7460155190
Test kit package size
480
Test Package Size
Cobas HPV 07460155190, 480 tests/kit
cobas® HPV Positive Control Kit, 07460171190, 16ml
HPV Negative Control Kit, 07002238190 , 16ml

cobas omni MGP Reagent, 06997546190, 480 tests
cobas omni Specimen Diluent , 06997511190, 4 x 875 ml
cobas omni Lysis Reagent, 06997538190, 4 x 875 ml
cobas omni Wash Reagent, 06997503190, 4
Identification name
7460171190
Test kit package size
480
Test Package Size
Cobas HPV 07460155190, 480 tests/kit
cobas® HPV Positive Control Kit, 07460171190, 16ml
HPV Negative Control Kit, 07002238190 , 16ml

cobas omni MGP Reagent, 06997546190, 480 tests
cobas omni Specimen Diluent , 06997511190, 4 x 875 ml
cobas omni Lysis Reagent, 06997538190, 4 x 875 ml
cobas omni Wash Reagent, 06997503190, 4
IVD Manufacturing Site(s)
Roche Molecular Systems, Inc.
1080 US Hwy 202 South
Branchburg Township,
8876
United States of America