Pregnancy (hCG) Rapid Test Midstream FHC-103H

GUDID 06970277512404

Pregnancy (hCG) Rapid Test Midstream

Hangzhou AllTest Biotech Co., Ltd.

Total human chorionic gonadotropin (HCG) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 06970277512404
• NIH Device Record Key: e0937480-b883-406f-bc4c-35e54b8a35a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pregnancy (hCG) Rapid Test Midstream
• Version Model Number: FHC-103H
• Catalog Number: FHC-103H
• 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	06970277512404 [Primary]

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: 2018-10-08
• Device Publish Date: 2018-09-05

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