ARCHITECT

Basic Information

• Brand Name: ARCHITECT
• Primary DI: 00380740002091
• Version / Model: 1P74-02
• Catalog Number: 01P7402
• Company Name: ABBOTT IRELAND
• Labeler DUNS: 989964119
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 5
• Public Version Date: 2024-02-21
• Public Version Status: Update
• Public Device Record Key: bd6cc9c1-a401-4896-b03f-94c1aa14b86f

Device Description

ARCHITECT Folate 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
CGN	ACID, FOLIC, RADIOIMMUNOASSAY	Clinical Chemistry	862.1295	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41931	Folate (vitamin B9) IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of folate (vitamin B9) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740002091	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Calibrators are sensitive to light. Store bottles in carton to protect from light.
• Type: Handling Environment Temperature
• Temperature Range: High: -20 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: High: -20 Degrees Celsius