ARCHITECT

Basic Information

• Brand Name: ARCHITECT
• Primary DI: 00380740000301
• Version / Model: 1E11-20
• Catalog Number: 01E1120
• 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: 2023-09-06
• Public Version Status: Update
• Public Device Record Key: ca0382e5-e6af-4e49-aad5-8271938f703f

Device Description

Gentamicin

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
LCD	ENZYME IMMUNOASSAY, GENTAMICIN	Clinical Toxicology	862.3450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61017	Gentamicin 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 antimicrobial drug gentamicin 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	00380740000301	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K060709	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not freeze reagents or expose reagents to temperatures above 32 degrees celcius.
• Type: Handling Environment Temperature
• Temperature Range: High: 29 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius