NEW CHOICE PLUS

GUDID 00677421001116

New Choice Plus One Step Pregnancy Test

SCI Medic, Inc.

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00677421001116
• NIH Device Record Key: b16260fb-840f-4aa1-bd95-283c6c1af915
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEW CHOICE PLUS
• Version Model Number: 00111
• Company DUNS: 117568595
• Company Name: SCI Medic, 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00677421001116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984075

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

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: 2023-04-07
• Device Publish Date: 2023-03-30

On-Brand Devices [NEW CHOICE PLUS]

• 00667742001117: ONE STEP PREGNANCY TEST
• 00677421001116: New Choice Plus One Step Pregnancy Test