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

Devices Manufactured by Hangzhou AllTest Biotech Co., Ltd.

• 16936983165416 - Multi-Drug 13 Drugs Rapid Test Cup: 2024-09-16 FDA Clia Waived, AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50/FYL1
• 16936983165447 - Alltest Multi-Drug 12 Drugs Rapid Test Cup: 2024-09-16 FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/OXY100/FYL1
• 16936983165454 - Alltest Multi-Drug 14 Drugs Rapid Test Cup: 2024-09-16 FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/PCP25/TCA1000/OXY100/FYL1
• 16936983165461 - Multi-Drug 12 Drugs Rapid Test Cup: 2024-09-16 FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/OXY100/FYL1
• 16936983165478 - Multi-Drug 14 Drugs Rapid Test Cup: 2024-09-16 FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/PCP25/TCA1000/OXY100/FYL1
• 16936983165522 - Multi-Drug 14 Drugs Rapid Test Cup: 2024-09-16 FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/PCP25/TCA1000/OXY100/FYL1)+(OXI/CRE/pH)
• 06936983166256 - iScreen Urine Test DX Drug Screen Tox Cup: 2024-09-16 25T, FDA, CLIA WAIVED (AMP500/BAR300/BUP10/BZO300/COC150/FTY1/MDMA500/MET500/MOP300/MTD300/OXY100/PCP25/TCA1000/THC50)+(OXI/CRE/
• 06936983167116 - Shinetell Digital Pregnancy Test: 2024-09-161T, FDA OTC
• 06936983167116 - Shinetell Digital Pregnancy Test: 2024-09-16 1T, FDA OTC