Family Wellness

GUDID 00032251056192

Early Result Pregnancy Test 2CT

FOURSTAR GROUP INC.

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00032251056192
• NIH Device Record Key: 78d045fb-4ad8-422f-a772-f3afdc24eee7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Family Wellness
• Version Model Number: 0903756
• Company DUNS: 656091279
• Company Name: FOURSTAR GROUP 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00032251056192 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150022

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-05-23
• Device Publish Date: 2018-05-14

On-Brand Devices [Family Wellness]

• 00032251057663: Early Result Pregnancy Test 1CT
• 00032251056192: Early Result Pregnancy Test 2CT