ARCHITECT

Basic Information

• Brand Name: ARCHITECT
• Primary DI: 00380740001803
• Version / Model: 1P34-25
• Catalog Number: 01P3425
• 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: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 4cff478f-858d-4276-a500-f8ab364411ea

Device Description

ARCHITECT iPhenytoin 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
DIP	ENZYME IMMUNOASSAY, DIPHENYLHYDANTOIN	Clinical Toxicology	862.3350	2
LGR	FLUORESCENCE POLARIZATION IMMUNOASSAY, DIPHENYLHYDANTOIN (TOTAL)	Clinical Toxicology	862.3350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60985	Phenytoin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the central nervous system drug phenytoin (e.g., dilantin) 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	00380740001803	GS1

Customer Contacts

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

Storage Conditions

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