SPOTCHECK

Basic Information

• Brand Name: SPOTCHECK
• Primary DI: 00725609000502
• Version / Model: 303-A980-00B
• Catalog Number: 303-A980-00B
• Company Name: ASTORIA-PACIFIC, INC.
• Labeler DUNS: 623238615
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-14
• Public Version: 4
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: 9ea6989b-a870-4680-bed9-1642acda68f3

Device Description

Uridyltransferase Blank Cartridge

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Clinical Chemistry	862.2170	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56677	Multichannel clinical chemistry analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents and incorporates multiple channels using two or more technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00725609000502	GS1

Premarket Submissions

Submission Number	Supplement Number
K883020	000