ARCHITECT

Basic Information

• Brand Name: ARCHITECT
• Primary DI: 00380740081911
• Version / Model: 1P06-02
• Catalog Number: 01P0602
• Company Name: ABBOTT LABORATORIES
• Labeler DUNS: 079226220
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 5
• Public Version Date: 2023-08-21
• Public Version Status: Update
• Public Device Record Key: 336785b3-3eec-4964-b710-ecf598f613f2

Device Description

ARCHITECT Transplant Pretreatment Tubes

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
MKW	CYCLOSPORINE	Clinical Chemistry	862.1235	2
MLM	ENZYME IMMUNOASSAY, TRACROLIMUS	Clinical Chemistry	862.1678	2
NRP	Sirolimus test system	Clinical Toxicology	862.3840	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62225	Assay container IVD, single-use	A reservoir (e.g., bottle, tube, cup) intended to be used to contain volumes of reagent, buffers, biological specimens, or other materials in preparation for in vitro diagnostic testing procedures performed in the laboratory. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740081911	GS1
Unit of Use	00380740138875	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K070820	000
K070822	000
K080751	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius