Identity
- Trade Name
- cobas HPV for use on the cobas 6800/8800 Systems FDA PMA
- Generic Name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS FDA PMA
Identifiers
- PMA Number
- P190028 FDA PMA
- FDA Product Code
- MAQ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The cobas HPV is a Kit, DNA Detection, Human Papillomavirus (generic name), designed for qualitative in vitro detection of Human Papillomavirus (HPV) DNA in clinician-collected cervical specimens. It identifies high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68, supporting cervical cancer screening and risk assessment as per professional guidelines.
This test is intended for use on the cobas 6800/8800 Systems and requires specimens collected with an endocervical brush/spatula or broom, preserved in ThinPrep Pap Test PreservCyt Solution. Supplied as a single-use kit, it is classified as a Class III device under FDA regulations and has received FDA_PMA authorization (PMA Number: P190028). No sterility or MRI safety information is specified.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P190028 | Class III | Active |
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Manufacturer
- Manufacturer
- Roche Molecular Systems, Inc.
Sources (1)
- FDA PMA P190028 24 fields · synced Sep 18, 2026