Alinity m

Basic Information

• Brand Name: Alinity m
• Primary DI: 00884999048898
• Version / Model: 09N19-012
• Catalog Number: 09N19-012
• Company Name: ABBOTT MOLECULAR INC.
• Labeler DUNS: 878263359
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-18
• Public Version: 1
• Public Version Date: 2022-05-26
• Public Version Status: New
• Public Device Record Key: b2a36e8b-60de-4c4a-94ea-a8f74a105c13

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OOI	real time Nucleic acid amplification system	Clinical Chemistry	862.2570	2
LSL	DNA-REAGENTS, NEISSERIA	Microbiology	866.3390	2
MKZ	DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA	Microbiology	866.3120	1
OUY	Trichomonas vaginalis nucleic acid amplification test system	Immunology	866.3860	2
QEP	Nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections	Microbiology	866.3393	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33722	General-purpose absorbent tip applicator/swab, single-use	A hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device.	No	Active
47775	General specimen container IVD, no additive/medium	An empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30884999050410	GS1	Case	10	In Commercial Distribution
Package	20884999050413	GS1		50	In Commercial Distribution
Primary	00884999048898	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K202977	000

Storage Conditions

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