Alinity m

Basic Information

• Brand Name: Alinity m
• Primary DI: 00884999048621
• Version / Model: 09N15-085
• Catalog Number: 09N15-085
• Company Name: ABBOTT MOLECULAR INC.
• Labeler DUNS: 878263359
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-02
• Public Version: 1
• Public Version Date: 2024-01-10
• Public Version Status: New
• Public Device Record Key: 09d8602f-88e1-41d6-a682-3dc99dab38df

Device Description

Alinity m HR HPV CTRL Kit

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: No
• 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
MAQ	KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
52766	Human papillomavirus (HPV) high-risk strain nucleic acid IVD, control	A material that is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple high-risk strains of human papillomavirus (HPV) associated with cervical cancer, which may include types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and/or 68 in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884999048621	GS1

Premarket Submissions

Submission Number	Supplement Number
P230003	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – -15 Degrees Celsius