SPOTCHECK

Basic Information

• Brand Name: SPOTCHECK
• Primary DI: 00725609000526
• Version / Model: 82-0200P6K
• Catalog Number: 82-0200P6K
• 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: 7ec89153-e5a3-4a73-b97f-b2ea9e09d97c

Device Description

MS/MS Blood Spot Controls; Dried Blood Spots (containing Amino Acids, Free Carnitine, Acylcarnitine, and Succinylacetone) for Quality Control Use with Tandem Mass Spectrometry (MS/MS) Newborn Screening Systems

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: 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
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58192	Multiple amino acid/carnitine metabolite IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple amino acids and carnitine metabolites associated with metabolic disorders of a newborn in a clinical specimen. Analytes detected may include all amino acids, free carnitine, acylcarnitine and/or succinylacetone.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00725609000526	GS1