ARCHITECT

Basic Information

• Brand Name: ARCHITECT
• Primary DI: 00380740013042
• Version / Model: 7D80-31
• Catalog Number: 07D8031
• Company Name: ABBOTT LABORATORIES
• Labeler DUNS: 079226220
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-31
• Public Version: 3
• Public Version Date: 2024-02-21
• Public Version Status: Update
• Public Device Record Key: aad6f25c-ee3d-4f42-89f4-44ffde3a69fb

Device Description

Lipase

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: Yes
• 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
CHI	LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE	Clinical Chemistry	862.1465	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53114	Lipoprotein lipase IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the lipid hydrolysing enzyme lipoprotein lipase in a clinical specimen, using a spectrophotometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740013042	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: High: 29 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius