SPOTCHECK

Basic Information

• Brand Name: SPOTCHECK
• Primary DI: 00725609000601
• Version / Model: 81-1100-05K
• Catalog Number: 81-1100-05K
• Company Name: ASTORIA-PACIFIC, INC.
• Labeler DUNS: 623238615
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-17
• Public Version: 1
• Public Version Date: 2020-12-25
• Public Version Status: New
• Public Device Record Key: e48c26d2-2f0b-4c05-a962-7e4821f56d88

Device Description

Phenylalanine Neonatal Screening Kit, 500 Test; An Enzymatic Colorimetric Assay for the Quantitative Determination of Phenylalanine Levels in Neonates

Device Characteristics

• Single Use: Yes
• 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: 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
JNB	Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine	Clinical Chemistry	862.1555	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43771	Phenylalanine IVD, kit, enzyme fluorescence	A collection of reagents and other associated materials intended to be used for the quantitative measurement of phenylalanine in a clinical specimen, using an enzyme fluorescence method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00725609000601	GS1

Premarket Submissions

Submission Number	Supplement Number
K974047	000