Cervista

Basic Information

• Brand Name: Cervista
• Primary DI: 15420045500150
• Version / Model: HPV HR (768 Reactions)
• Catalog Number: PRD-00804
• Company Name: Hologic, Inc.
• Labeler DUNS: 050579217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-07-30
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 8dbe6cea-bc78-49a6-92cc-b91f0a1b66a0

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MAQ	KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
49997	Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple high-risk strains of human papillomavirus (HPV) associated with cervical cancer, which may include types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and/or 68 in a clinical specimen, using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045500150	GS1

Premarket Submissions

Submission Number	Supplement Number
P080014	020