hCG Pregnancy Serum/Urine Combo Test Cassette HCG-C23

GUDID 06952804801205

ASSURE TECH. (HANGZHOU) CO., LTD.

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• Primary Device ID: 06952804801205
• NIH Device Record Key: 2ce1e8c5-313d-493e-86bb-1b1f7aded83f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: hCG Pregnancy Serum/Urine Combo Test Cassette
• Version Model Number: 1.0
• Catalog Number: HCG-C23
• Company DUNS: 530757741
• Company Name: ASSURE TECH. (HANGZHOU) 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06952804801205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152768

FDA Product Code

• JHI: Visual, Pregnancy Hcg, Prescription Use

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: 2017-02-04

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