Cervista Manual System

Basic Information

• Brand Name: Cervista Manual System
• Primary DI: 15420045501058
• Version / Model: Cervista Manual System Computer
• Company Name: Hologic, Inc.
• Labeler DUNS: 018925968
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-02
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d1e32d8c-42d8-476d-8342-0b26f3cb255b

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• 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
60737	Nucleic acid sample preparation instrument IVD, semi-automated	A mains electricity (AC-powered) laboratory instrument intended to be used for the pre-analytical preparation of samples for downstream nucleic acid amplification/analysis. The instrument may be used to prepare various sample types through one or more pre-analytical steps which may include cell disruption, lysis, nucleic acid extraction, enzymatic digestion, nucleic acid purification, and/or nucleic acid thermal incubation. The device operates with minimal technician involvement and automation of some but not all procedural steps.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045501058	GS1

Premarket Submissions

Submission Number	Supplement Number
P080014	020