ARCHITECT

Basic Information

• Brand Name: ARCHITECT
• Primary DI: 00380740007768
• Version / Model: 4P53-10
• Catalog Number: 04P5310
• Company Name: Abbott Ireland Diagnostics
• Labeler DUNS: 985307301
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-11-18
• Public Version: 3
• Public Version Date: 2024-01-08
• Public Version Status: Update
• Public Device Record Key: e61e3e6c-84d3-488f-93a2-7f3144b37a11

Device Description

ARCHITECT HBsAg Qualitative 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
42000	Hepatitis B virus surface antigen 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 Hepatitis B virus surface antigen in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740007768	GS1

Customer Contacts

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

Storage Conditions

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