ARCHITECT

Basic Information

• Brand Name: ARCHITECT
• Primary DI: 00380740002046
• Version / Model: 1P65-25
• Catalog Number: 01P6525
• Company Name: Abbott GmbH
• Labeler DUNS: 315786293
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-06
• Public Version: 3
• Public Version Date: 2020-06-22
• Public Version Status: Update
• Public Device Record Key: 77100d6e-f5f2-4793-9302-e5b6c53d62d4

Device Description

ARCHITECT Anti-CCP 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
NHX	ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)	Immunology	866.5775	2
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE	Clinical Chemistry	862.1150	2
JJY	Multi-analyte controls, all kinds (assayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61080	Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to cyclic citrullinated peptide (anti-CCP) 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	00380740002046	GS1

Customer Contacts

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

Storage Conditions

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