Personal Care

GUDID 00808829120028

Pregnancy test stick

DELTA BRANDS INC.

Human chorionic gonadotropin alpha-subunit (alpha-HCG) IVD, calibrator

• Primary Device ID: 00808829120028
• NIH Device Record Key: 5f861f24-cbe4-4b87-871c-009c33f2ff9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Personal Care
• Version Model Number: 12002
• Company DUNS: 102672008
• Company Name: DELTA BRANDS 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: 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	00808829120028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123050

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: 2021-09-06
• Device Publish Date: 2021-08-27

On-Brand Devices [Personal Care]

• 00808829120028: Pregnancy test stick
• 00048155920200: Cassette