ARCHITECT

Basic Information

• Brand Name: ARCHITECT
• Primary DI: 00380740017422
• Version / Model: 8K27-01
• Catalog Number: 08K2701
• 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: a5c5d408-86a3-4ec7-83b2-7b0cf926e0dc

Device Description

ARCHITECT DHEA-S Calibrators

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
JJX	SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)	Clinical Chemistry	862.1660	1
JIT	CALIBRATOR, SECONDARY	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54140	Dehydroepiandrosterone sulfate (DHEAS) IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of dehydroepiandrosterone sulfate (DHEAS) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740017422	GS1

Customer Contacts

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

Storage Conditions

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