ABBOTT PRISM

Basic Information

• Brand Name: ABBOTT PRISM
• Primary DI: 00380740012403
• Version / Model: 7B36-01
• Catalog Number: 07B3601
• Company Name: ABBOTT LABORATORIES
• Labeler DUNS: 079226220
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 6
• Public Version Date: 2023-08-03
• Public Version Status: Update
• Public Device Record Key: f3d40797-16dc-4763-9264-ec79dbcd66a8
• Distribution End Date: 2023-03-21

Device Description

ABBOTT PRISM SAMPLE CUPS

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: 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
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740012403	GS1
Unit of Use	00380740132378	GS1

Customer Contacts

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