ARCHITECT

Basic Information

• Brand Name: ARCHITECT
• Primary DI: 00380740001339
• Version / Model: 1L76-01
• Catalog Number: 01L7601
• 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: 2023-12-15
• Public Version Status: Update
• Public Device Record Key: c1a58cec-80bc-4b27-85d2-54cce1cc8cae

Device Description

ARCHITECT Sirolimus 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
JIT	CALIBRATOR, SECONDARY	Clinical Chemistry	862.1150	2
NRP	Sirolimus test system	Clinical Toxicology	862.3840	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55447	Rapamycin (sirolimus) therapeutic drug monitoring IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of the immunosuppressant drug rapamycin (sirolimus) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740001339	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K070822	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: High: 0 Degrees Celsius