FINDER

GUDID 00819704020340

FINDER G6PD Test (Box of 16)

BAEBIES, INC.

Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme fluorescence

• Primary Device ID: 00819704020340
• NIH Device Record Key: af857fdc-b6d3-4849-a126-1055f0b1ce62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FINDER
• Version Model Number: 100-000009
• Company DUNS: 079264306
• Company Name: BAEBIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (919) 420-3329
• Email: findsupport@baebies.com
• Phone: +1 (919) 420-3329
• Email: findsupport@baebies.com
• Phone: +1 (919) 420-3329
• Email: findsupport@baebies.com
• Phone: +1 (919) 420-3329
• Email: findsupport@baebies.com
• Phone: +1 (919) 420-3329
• Email: findsupport@baebies.com
• Phone: +1 (919) 420-3329
• Email: findsupport@baebies.com
• Phone: +1 (919) 420-3329
• Email: findsupport@baebies.com
• Phone: +1 (919) 420-3329
• Email: findsupport@baebies.com
• Phone: +1 (919) 420-3329
• Email: findsupport@baebies.com
• Phone: +1 (919) 420-3329
• Email: findsupport@baebies.com
• Phone: +1 (919) 420-3329
• Email: findsupport@baebies.com
• Phone: +1 (919) 420-3329
• Email: findsupport@baebies.com
• Phone: +1 (919) 420-3329
• Email: findsupport@baebies.com
• Phone: +1 (919) 420-3329
• Email: findsupport@baebies.com
• Phone: +1 (919) 420-3329
• Email: findsupport@baebies.com
• Phone: +1 (919) 420-3329
• Email: findsupport@baebies.com
• Phone: +1 (919) 420-3329
• Email: findsupport@baebies.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819704020340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201049

FDA Product Code

• JBF: Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-10
• Device Publish Date: 2025-01-31

On-Brand Devices [FINDER]

• 00819704020395: FINDER Pipette, 50µL
• 00819704020388: FINDER Pipette, 50µL (pack of 5 pipettes)
• 00819704020364: FINDER G6PD TEST (Unit of Use)
• 00819704020340: FINDER G6PD Test (Box of 16)
• 00819704020333: FINDER Instrument