One + Step

GUDID 05055718942314

NANTONG EGENS BIOLOGY TECHNIC CO., LTD.

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

• Primary Device ID: 05055718942314
• NIH Device Record Key: ea2bb8fe-39d3-4e44-965e-6bd942940c7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: One + Step
• Version Model Number: HCG-U11
• Company DUNS: 654510689
• Company Name: NANTONG EGENS BIOLOGY TECHNIC 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	05055718942314 [Primary]

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: 2017-04-19

On-Brand Devices [One + Step]

• 05055718942376: HCG-U11
• 05055718942345: HCG-U23
• 05055718942314: HCG-U11
• 05055718942307: HCG-U11
• 05055718942284: HCG-U35