Universal

GUDID 06923304621112

Weihai Kangzhou Biotechnology Engineering Co., Ltd

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 06923304621112
• NIH Device Record Key: ac45dc32-c3ba-47d5-8ebb-07eb7eb0d6ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal
• Version Model Number: cassette
• 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: false
• Serial Number: true
• 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	06923304621112 [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: 2023-06-08
• Device Publish Date: 2023-05-31

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
• 06923304600032 - INSTANT Aid By PUR-est: 2023-08-23
• 06923304611113 - INSTANT Aid By PUR-est: 2023-08-23