Alinity

Basic Information

• Brand Name: Alinity
• Primary DI: 00380740132705
• Version / Model: 04R4701
• Catalog Number: 04R4701
• Company Name: ABBOTT LABORATORIES
• Labeler DUNS: 117245596
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2018-05-31
• Public Version: 7
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: ca2c91e2-9160-4562-9d6c-5549ccd4a384

Device Description

Alinity Reagent Replacement Caps

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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
JJE	ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE	Clinical Chemistry	862.2160	1
MZA	Test, equipment, automated bloodborne pathogen	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
56701	Chemiluminescent immunoassay analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers (e.g., protein, drug, hormone, microbial toxin) in a clinical specimen, using an immunological method that utilizes a chemiluminescent detection system together with sample processing, data processing and/or data display software.	No	Active
56676	Multiple clinical chemistry analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technologies (e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence). Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740132705	GS1
Unit of Use	00380740163488	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 40 Degrees Celsius