One Step FSH Urine midstream Test

GUDID 06936983131018

One Step FSH Urine midstream Test, 2T, EN

Hangzhou AllTest Biotech Co., Ltd.

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

• Primary Device ID: 06936983131018
• NIH Device Record Key: 7268689a-af97-4b08-b900-4d88ae436a2f
• Commercial Distribution Discontinuation: 2025-08-29
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: One Step FSH Urine midstream Test
• Version Model Number: 1
• Company DUNS: 543254717
• Company Name: Hangzhou AllTest Biotech Co., Ltd.
• Device Count: 2
• 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	06936983131018 [Primary]
GS1	86936983131014 [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

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