ARCHITECT

Basic Information

• Brand Name: ARCHITECT
• Primary DI: 00380740003197
• Version / Model: 2K41-10
• Catalog Number: 02K4110
• Company Name: ABBOTT LABORATORIES
• Labeler DUNS: 079226220
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-06
• Public Version: 4
• Public Version Date: 2023-09-21
• Public Version Status: Update
• Public Device Record Key: 792c2c5d-17c2-4ff9-a14c-66aa2d847093

Device Description

ARCHITECT STAT Troponin-I 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: Yes
• 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
JJX	SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54012	Troponin I 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 troponin I in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740003197	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K041194	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: High: -.1 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: High: -10 Degrees Celsius