Clarisse

GUDID 00808829111903

DELTA BRANDS INC.

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

• Primary Device ID: 00808829111903
• NIH Device Record Key: 548227ae-eebf-4a0a-af0b-4cc4abd041ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clarisse
• Version Model Number: Cassette
• Company DUNS: 102672008
• Company Name: DELTA BRANDS INC.
• Device Count: 2
• 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	00808829111903 [Primary]
GS1	00808829113358 [Unit of Use]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-17

On-Brand Devices [Clarisse]

• 00808829111903: Cassette
• 00808829120615: Over-the-counter, One Step human Chorionic Gonadotropin hCG. Colloidal Gold Urine Pregnancy. fo
• 00808829125672: Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy - (