APTIMA®

Basic Information

• Brand Name: APTIMA®
• Primary DI: 15420045504233
• Version / Model: KIT, CONTROLS, HIV QUANT, US IVD
• Catalog Number: PRD-03567
• Company Name: Hologic, Inc.
• Labeler DUNS: 050579217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-18
• Public Version: 4
• Public Version Date: 2023-10-11
• Public Version Status: Update
• Public Device Record Key: d7d66883-562d-4910-91c6-465e534dacb5

Device Description

Aptima® HIV-1 Quant Dx Assay Controls Kit.

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
MZF	Test, hiv detection	Microbiology	866.3956	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48466	HIV1 nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of human immunodeficiency virus 1 (HIV1) nucleic acid in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045504233	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
BP150318	000

Storage Conditions

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