ARCHITECT

Basic Information

• Brand Name: ARCHITECT
• Primary DI: 00380740175146
• Version / Model: 9D93-22
• Catalog Number: 09D9322
• Company Name: Abbott GmbH
• Labeler DUNS: 315786293
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-15
• Public Version: 2
• Public Version Date: 2023-04-25
• Public Version Status: Update
• Public Device Record Key: fd0d802f-3357-417d-9699-8cda8a6a042a

Device Description

Apolipoprotein B

Device Characteristics

• Single Use: No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DFC	LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL	Immunology	866.5600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53447	Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of apolipoprotein B (Apo B) lipid in a clinical specimen, using a nephelometry/turbidimetry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740175146	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius