Aptima®

Basic Information

• Brand Name: Aptima®
• Primary DI: 15420045506770
• Version / Model: KIT, TER, HBV, VL, 100T, US IVD
• Catalog Number: PRD-04081
• Company Name: Hologic, Inc.
• Labeler DUNS: 050579217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-30
• Public Version: 5
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: 76406bb6-a6b8-47bb-bdac-d4b8a5493454

Device Description

Aptima® HBV Quant Assay Target Enhancer Reagent.

Device Characteristics

• Single Use: Yes
• 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
MKT	Hepatitis Viral B Dna Detection	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
48219	HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of human immunodeficiency virus 1 (HIV1) nucleic acid, Hepatitis C virus nucleic acid, and Hepatitis B 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	15420045506770	GS1

Customer Contacts

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