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.

• 06936983179973 - Discover Multi-Drug 8 Drugs Rapid Test Cup(Urine): 2025-03-19 MOP(OPI)300/OXY100/COC150/MET500/MTD300/BZO300/AMP500/BUP10, 25T, FDA CLIA WAIVED
• 06936983179980 - Discover Multi-Drug 9 Drugs Rapid Test Cup(Urine): 2025-03-19 MOP(OPI)300/OXY100/COC150/MET500/MTD300/BZO300/AMP500/THC50/BUP10, 25T, FDA CLIA WAIVED
• 06936983177221 - FirstCheck HOME DRUG TEST: 2025-02-24 ABTDTHO11701A, 1T/kit, THC50
• 06936983177238 - FirstCheck HOME DRUG TEST: 2025-02-24 ABTDOAO16701A, 1T/kit, AMP500/COC150/FYL1/MET500/MOP300/THC50
• 06936983177245 - FirstCheck HOME DRUG TEST: 2025-02-24 ABTDOAO114701A, 1T/kit, AMP500/BAR300/BUP10/BZO300/COC150/FYL1/MDMA500/MET500/MOP300/MTD300/OXY100/PCP25/TCA1000/THC50
• 06936983177252 - FirstCheck Cotinine Oral Fluid Test: 2025-02-24 ABTDCTCUBO0101, 1T/kit, COT20
• 06936983177689 - FirstCheck HOME DRUG TEST: 2025-02-24 REF: ABTDOAO17701A, FDA OTC, 1T/kit, AMP500/COC150/FYL1/MDMA500/MET500/MOP300/THC50
• 06936983168649 - DrugTect Multi-Drug 14 Drugs Rapid Urine Test Cup: 2025-02-21 FDA Clia Waived, 25T, MOP300/MDMA500/OXY100/PCP25/COC150/MTD300/BAR300/BZO300/AMP500/MET500/TCA1000/THC50/BUP10/FYL1 + (OXI/SG