SPOTCHECK

Basic Information

• Brand Name: SPOTCHECK
• Primary DI: 00725609000144
• Version / Model: 81-8000-60K
• Catalog Number: 81-8000-60K
• 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: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 0edc9880-41b2-43a8-8584-824a7b5a6f1d

Device Description

Biotinidase Microplate Reagent Kit, 60 Plate

Device Characteristics

• Single Use: Yes
• 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
NAK	System,Test,Biotinidase	Clinical Chemistry	862.1118	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52960	Biotinidase IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the enzyme biotinidase 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	00725609000144	GS1

Premarket Submissions

Submission Number	Supplement Number
K080294	000