ARCHITECT

Basic Information

• Brand Name: ARCHITECT
• Primary DI: 00380740011154
• Version / Model: 6L23-25
• Catalog Number: 06L2325
• Company Name: Abbott GmbH
• Labeler DUNS: 315786293
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-11-18
• Public Version: 8
• Public Version Date: 2024-02-22
• Public Version Status: Update
• Public Device Record Key: d35f11ca-2c3d-4860-9663-eadeb1b35925

Device Description

ARCHITECT CORE-M Reagent Kit

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
48298	Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the Hepatitis B virus core antigen in a clinical specimen, using a chemiluminescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740011154	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P060035	001
P060035	002
P060035	003
P060035	006
P060035	008
P060035	030
P060035	031
P060035	032
P060035	038

Storage Conditions

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