SPOTCHECK

Basic Information

• Brand Name: SPOTCHECK
• Primary DI: 00725609000625
• Version / Model: 85-2000-05K
• Catalog Number: 85-2000-05K
• 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: a14fd803-cc20-43ed-b61d-6b6c43131d87

Device Description

17-OHP Neonatal Screening Kit, 480 Test; An Enzyme Immunoassay (EIA) for the Quantitative Determination of 17α-Hydroxyprogesterone (17-OHP) Levels in Neonates

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
JLX	Radioimmunoassay, 17-Hydroxyprogesterone	Clinical Chemistry	862.1395	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63577	17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of 17-hydroxyprogesterone in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis of congenital adrenal hyperplasia (CAH).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00725609000625	GS1

Premarket Submissions

Submission Number	Supplement Number
K060452	000