ZIOXX

GUDID 06923304600049

Weihai Kangzhou Biotechnology Engineering Co., Ltd

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

• Primary Device ID: 06923304600049
• NIH Device Record Key: 44c3b872-fd2d-4acd-9877-e9f588700af2
• Commercial Distribution Discontinuation: 2023-09-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ZIOXX
• Version Model Number: midstream
• Company DUNS: 560448061
• Company Name: Weihai Kangzhou Biotechnology Engineering Co., Ltd
• 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	06923304600049 [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: 2023-09-15
• Device Publish Date: 2023-09-07

Devices Manufactured by Weihai Kangzhou Biotechnology Engineering Co., Ltd

• 06923304621136 - kangzhou: 2024-05-02
• 06923304600087 - MaYa: 2024-03-06
• 06923304600070 - Oichid: 2024-02-09
• 06923304611120 - FERTICARE: 2024-01-19
• 06923304611137 - FERTICARE: 2024-01-19
• 06923304600049 - ZIOXX: 2023-09-15
• 06923304600049 - ZIOXX: 2023-09-15
• 06923304600032 - INSTANT Aid By PUR-est: 2023-08-23
• 06923304611113 - INSTANT Aid By PUR-est: 2023-08-23