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0466-046-00

SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0466-046-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
cobas 4800 HPV Test
Assay Type
NAT (nucleic acid testing)
IVD Public Report Category
HPV NAT
Regulatory Version Submitted To PQ
USFDA: Premarket Approval (PMA)
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
05235901190
Test kit package size
240
Test Package Size
240 tests/kit p/n 05235880190; 960 tests/kit p/n 05235898190 - different volumes and /p/n per kit size, cobas® 4800 HPV MasterMix and cobas® 4800 HPV Mg/Mn Solution
cobas® 4800 HPV Controls Kit P/N: 05235855190
cobas® 4800 System Sample Preparation Kit P/N: 05235782190 (240) P/N: 05235804190 (960)
cobas® 4800 System Wash Buffer Kit P/N: 05235863190 (240) P/N: 05235871190 (960)
cobas® 4800 System Liquid Cytology Preparation Kit P/N: 05235812190 (240) P/N: 05235839190 (960)
Identification name
05235910190
Test kit package size
960
Test Package Size
240 tests/kit p/n 05235880190; 960 tests/kit p/n 05235898190 - different volumes and /p/n per kit size, cobas® 4800 HPV MasterMix and cobas® 4800 HPV Mg/Mn Solution
cobas® 4800 HPV Controls Kit P/N: 05235855190
cobas® 4800 System Sample Preparation Kit P/N: 05235782190 (240) P/N: 05235804190 (960)
cobas® 4800 System Wash Buffer Kit P/N: 05235863190 (240) P/N: 05235871190 (960)
cobas® 4800 System Liquid Cytology Preparation Kit P/N: 05235812190 (240) P/N: 05235839190 (960)
Identification name
05235812190
Test kit package size
240
Test Package Size
240 tests/kit p/n 05235880190; 960 tests/kit p/n 05235898190 - different volumes and /p/n per kit size, cobas® 4800 HPV MasterMix and cobas® 4800 HPV Mg/Mn Solution
cobas® 4800 HPV Controls Kit P/N: 05235855190
cobas® 4800 System Sample Preparation Kit P/N: 05235782190 (240) P/N: 05235804190 (960)
cobas® 4800 System Wash Buffer Kit P/N: 05235863190 (240) P/N: 05235871190 (960)
cobas® 4800 System Liquid Cytology Preparation Kit P/N: 05235812190 (240) P/N: 05235839190 (960)
Identification name
05235839190
Test kit package size
960
Test Package Size
240 tests/kit p/n 05235880190; 960 tests/kit p/n 05235898190 - different volumes and /p/n per kit size, cobas® 4800 HPV MasterMix and cobas® 4800 HPV Mg/Mn Solution
cobas® 4800 HPV Controls Kit P/N: 05235855190
cobas® 4800 System Sample Preparation Kit P/N: 05235782190 (240) P/N: 05235804190 (960)
cobas® 4800 System Wash Buffer Kit P/N: 05235863190 (240) P/N: 05235871190 (960)
cobas® 4800 System Liquid Cytology Preparation Kit P/N: 05235812190 (240) P/N: 05235839190 (960)
Identification name
05235855190
Test Package Size
240 tests/kit p/n 05235880190; 960 tests/kit p/n 05235898190 - different volumes and /p/n per kit size, cobas® 4800 HPV MasterMix and cobas® 4800 HPV Mg/Mn Solution
cobas® 4800 HPV Controls Kit P/N: 05235855190
cobas® 4800 System Sample Preparation Kit P/N: 05235782190 (240) P/N: 05235804190 (960)
cobas® 4800 System Wash Buffer Kit P/N: 05235863190 (240) P/N: 05235871190 (960)
cobas® 4800 System Liquid Cytology Preparation Kit P/N: 05235812190 (240) P/N: 05235839190 (960)
Identification name
05235863190
Test kit package size
240
Test Package Size
240 tests/kit p/n 05235880190; 960 tests/kit p/n 05235898190 - different volumes and /p/n per kit size, cobas 4800 HPV MasterMix and cobas 4800 HPV Mg/Mn Solution
cobas 4800 HPV Controls Kit P/N: 05235855190
cobas 4800 System Sample Preparation Kit P/N: 05235782190 (240) P/N: 05235804190 (960)
cobas 4800 System Wash Buffer Kit P/N: 05235863190 (240) P/N: 05235871190 (960)
cobas 4800 System Liquid Cytology Preparation Kit P/N: 05235812190 (240) P/N: 05235839190 (960)
Identification name
05235871190
Test kit package size
960
Test Package Size
240 tests/kit p/n 05235880190; 960 tests/kit p/n 05235898190 - different volumes and /p/n per kit size, cobas 4800 HPV MasterMix and cobas 4800 HPV Mg/Mn Solution
cobas 4800 HPV Controls Kit P/N: 05235855190
cobas 4800 System Sample Preparation Kit P/N: 05235782190 (240) P/N: 05235804190 (960)
cobas 4800 System Wash Buffer Kit P/N: 05235863190 (240) P/N: 05235871190 (960)
cobas 4800 System Liquid Cytology Preparation Kit P/N: 05235812190 (240) P/N: 05235839190 (960)
Identification name
05235880190
Test kit package size
240
Test Package Size
240 tests/kit p/n 05235880190; 960 tests/kit p/n 05235898190 - different volumes and /p/n per kit size, cobas 4800 HPV MasterMix and cobas 4800 HPV Mg/Mn Solution
cobas 4800 HPV Controls Kit P/N: 05235855190
cobas 4800 System Sample Preparation Kit P/N: 05235782190 (240) P/N: 05235804190 (960)
cobas 4800 System Wash Buffer Kit P/N: 05235863190 (240) P/N: 05235871190 (960)
cobas 4800 System Liquid Cytology Preparation Kit P/N: 05235812190 (240) P/N: 05235839190 (960)
Identification name
05235898190
Test kit package size
960
Test Package Size
240 tests/kit p/n 05235880190; 960 tests/kit p/n 05235898190 - different volumes and /p/n per kit size, cobas 4800 HPV MasterMix and cobas 4800 HPV Mg/Mn Solution
cobas 4800 HPV Controls Kit P/N: 05235855190
cobas 4800 System Sample Preparation Kit P/N: 05235782190 (240) P/N: 05235804190 (960)
cobas 4800 System Wash Buffer Kit P/N: 05235863190 (240) P/N: 05235871190 (960)
cobas 4800 System Liquid Cytology Preparation Kit P/N: 05235812190 (240) P/N: 05235839190 (960)
IVD Manufacturing Site(s)
Roche Molecular Systems, Inc.
1080 US Hwy 202 South
Branchburg Township,
8876
United States of America