CLARISSE

GUDID 00808829125672

Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy - (1) Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.

DELTA BRANDS INC.

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

• Primary Device ID: 00808829125672
• NIH Device Record Key: 0eb48c7b-18c9-4e70-9691-25782a9f6190
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLARISSE
• Version Model Number: Test midstream I
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• 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	00808829125672 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183097

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: 2024-03-15
• Device Publish Date: 2024-03-07

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 - (