Shinetell Digital Pregnancy Test

GUDID 06936983167116

1T, FDA OTC

Hangzhou AllTest Biotech Co., Ltd.

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

• Primary Device ID: 06936983167116
• NIH Device Record Key: a3ecb671-8b5f-4a41-a194-a7d0c7a2bb60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shinetell Digital Pregnancy Test
• Version Model Number: 1
• Company DUNS: 543254717
• Company Name: Hangzhou AllTest Biotech 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06936983167116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241978

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: 2024-09-16
• Device Publish Date: 2024-09-08

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