ARCHITECT

Basic Information

• Brand Name: ARCHITECT
• Primary DI: 00380740001421
• Version / Model: 1L79-35
• Catalog Number: 01L7935
• 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: 7
• Public Version Date: 2023-02-23
• Public Version Status: Update
• Public Device Record Key: 00f8eeed-f8c2-4a7e-b3e1-1c210123aaf1

Device Description

ARCHITECT Anti-HCV 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
MZO	ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS	Unknown		2

GMDN Terms

Code	Name	Definition	Implantable	Status
48366	Hepatitis C virus total antibody IVD, kit, chemiluminescent assay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis C virus 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	00380740001421	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P050042	002
P050042	003
P050042	005
P050042	006
P050042	007
P050042	010
P050042	012
P050042	042
P050042	045

Storage Conditions

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