One Step One Step FSH Urine test strip

GUDID 86936983131021

One Step One Step FSH Urine test strip, 5T, EN

Hangzhou AllTest Biotech Co., Ltd.

Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, clinical

• Primary Device ID: 86936983131021
• NIH Device Record Key: ad2bb923-9ff4-4ce9-96f1-d110df5aa64f
• Commercial Distribution Discontinuation: 2025-08-29
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: One Step One Step FSH Urine test strip
• Version Model Number: 1
• Company DUNS: 543254717
• Company Name: Hangzhou AllTest Biotech Co., Ltd.
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06936983131025 [Primary]
GS1	86936983131021 [Unit of Use]

FDA Product Code

• NGA: Test, Follicle Stimulating Hormone (Fsh), 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: 2025-09-08
• Device Publish Date: 2025-08-29

Devices Manufactured by Hangzhou AllTest Biotech Co., Ltd.

• 06936983131018 - One Step FSH Urine midstream Test: 2025-09-08 One Step FSH Urine midstream Test, 2T, EN
• 86936983131021 - One Step One Step FSH Urine test strip: 2025-09-08One Step One Step FSH Urine test strip, 5T, EN
• 86936983131021 - One Step One Step FSH Urine test strip: 2025-09-08 One Step One Step FSH Urine test strip, 5T, EN
• 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