SPOTCHECK

Basic Information

• Brand Name: SPOTCHECK
• Primary DI: 00725609000243
• Version / Model: 80-8065P10K
• Catalog Number: 80-8065P10K
• 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: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 3e113ea3-2cca-4e7d-bf7e-e06f2f030081

Device Description

Biotinidase System Control, 10 x 50 mL

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
NAK	System,Test,Biotinidase	Clinical Chemistry	862.1118	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52962	Biotinidase IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of the enzyme biotinidase in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00725609000243	GS1

Premarket Submissions

Submission Number	Supplement Number
K010844	000