Aptima®

Basic Information

• Brand Name: Aptima®
• Primary DI: 15420045506800
• Version / Model: KIT, CALIBRATOR, HCV QUANT, US IVD
• Catalog Number: PRD-03707
• Company Name: Hologic, Inc.
• Labeler DUNS: 050579217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-08
• Public Version: 4
• Public Version Date: 2023-10-12
• Public Version Status: Update
• Public Device Record Key: e72a281c-8fed-4812-8518-1023df6f2773

Device Description

Aptima® HCV Quant Dx Assay Calibrator.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: 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
MZP	ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS	Microbiology	866.3170	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41979	Hepatitis C virus nucleic acid IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of Hepatitis C virus nucleic acid in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045506800	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P160023	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -35 – -15 Degrees Celsius