ARCHITECT

Basic Information

• Brand Name: ARCHITECT
• Primary DI: 00380740011116
• Version / Model: 6L22-10
• Catalog Number: 06L2210
• Company Name: Abbott GmbH
• Labeler DUNS: 315786293
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-01-30
• Public Version: 5
• Public Version Date: 2023-12-13
• Public Version Status: Update
• Public Device Record Key: 8de340dd-7682-4ee0-801b-e682f3137eca

Device Description

ARCHITECT CORE Controls

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
LOM	Test, hepatitis b (b core, be antigen, be antibody, b core igm)	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
41984	Hepatitis B virus core total antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis B virus core antigen in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740011116	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P080023	001
P080023	002
P080023	003
P080023	006
P080023	008
P080023	040

Storage Conditions

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