Clarisse

GUDID 00808829120615

Over-the-counter, One Step human Chorionic Gonadotropin hCG. Colloidal Gold Urine Pregnancy. for in vitri diagnostic use only IVD. Test kit , midstream

DELTA BRANDS INC.

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• Primary Device ID: 00808829120615
• NIH Device Record Key: f9b9b323-71a9-44fe-b4e8-d896e5ec6a93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clarisse
• Version Model Number: Midstream
• 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

Customer Support Contacts

• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com
• Phone: 18563166027
• Email: serena@whkangzhou.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00808829120615 [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: 2022-04-04
• Device Publish Date: 2022-03-25

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 - (