ARCHITECT

Basic Information

• Brand Name: ARCHITECT
• Primary DI: 00380740054243
• Version / Model: 6K42-40
• Catalog Number: 06K4240
• Company Name: ABBOTT LABORATORIES
• Labeler DUNS: 079226220
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 7
• Public Version Date: 2024-02-21
• Public Version Status: Update
• Public Device Record Key: 589f45a7-634b-4ecc-8476-44dcf88c4705

Device Description

Quantia Immunoglobulin E

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
DGC	IGE, ANTIGEN, ANTISERUM, CONTROL	Immunology	866.5510	2
JJS	CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)	Clinical Chemistry	862.1660	1
JJX	SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61274	Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergen(s) in a clinical specimen, using a nephelometry/turbidimetry method. It is typically used to screen for allergies associated with certain conditions (e.g., food intolerance).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740054243	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K050493	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: High: 29 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Do not freeze.