Aptima

Basic Information

• Brand Name: Aptima
• Primary DI: 15420045500273
• Version / Model: Auto Detect Reagents
• Catalog Number: 303013
• 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: 2021-11-01
• Public Version Status: Update
• Public Device Record Key: 91e02618-fc15-4262-a2cd-46eeb8c742e6

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
LSL	DNA-REAGENTS, NEISSERIA	Microbiology	866.3390	2
MKZ	DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA	Microbiology	866.3120	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61193	Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD	A collection of reagents and other associated materials intended to be used to generate a chemiluminescent signal when performing an assay using a nucleic acid technique (NAT) on a clinical specimen. The kit is typically used in conjunction with luminescent-labelled nucleic acid oligonucleotide probes of known sequences and may also include reference material to optimise and verify performance of the luminometer instrument.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045500273	GS1