Aptima®

Basic Information

• Brand Name: Aptima®
• Primary DI: 15420045500280
• Version / Model: KIT, ASSAY FLUIDS, APTIMA, AS
• Catalog Number: 303014
• Company Name: Hologic, Inc.
• Labeler DUNS: 050579217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-17
• Public Version: 5
• Public Version Date: 2024-07-22
• Public Version Status: Update
• Public Device Record Key: ce246910-b0d7-4071-9c28-9d0c4b371110

Device Description

The Aptima® Assay Fluids Kit is for use on the Panther® System.

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MKZ	DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA	Microbiology	866.3120	1
LSL	DNA-REAGENTS, NEISSERIA	Microbiology	866.3390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61194	Nucleic acid technique (NAT) kit IVD	A collection of reagents and other associated materials intended to be used to optimise an assay performed using a nucleic acid technique (NAT) on a clinical specimen. The kit typically consists of a silicone oil to minimize evaporation, buffered solutions for washing steps and reaction stop reagents.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045500280	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius