ARCHITECT

Basic Information

• Brand Name: ARCHITECT
• Primary DI: 00380740190361
• Version / Model: 08K2804
• Catalog Number: 08K2804
• Company Name: Abbott GmbH
• Labeler DUNS: 315786293
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-15
• Public Version: 2
• Public Version Date: 2020-06-22
• Public Version Status: Update
• Public Device Record Key: a5963ee6-e3d6-440d-922b-767610ea93c5

Device Description

ARCHITECT BNP 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

GMDN Terms

Code	Name	Definition	Implantable	Status
47353	B-type natriuretic protein/N-terminal pro b-type natriuretic peptide 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 B-type natriuretic protein (BNP) and/or N-terminal pro b-type natriuretic peptide (NT-proBNP) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740190361	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K060964	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: -10 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: High: 0 Degrees Celsius