FINDER

Basic Information

• Brand Name: FINDER
• Primary DI: 00819704020364
• Version / Model: 110-000014
• Company Name: Baebies, Inc.
• Labeler DUNS: 079264306
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-31
• Public Version: 2
• Public Version Date: 2026-04-08
• Public Version Status: Update
• Public Device Record Key: a4316b98-2fc9-477c-9595-4f9d1ca7a781

Device Description

FINDER G6PD TEST (Unit of Use)

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
JBF	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening	Hematology	864.7360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55932	Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme fluorescence	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of glucose-6-phosphate dehydrogenase (G6PD) enzyme activity of red cells from 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	00819704020364	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K201049	000