HCG Home Use Pregnancy Test Midstream (Colloidal Gold)

GUDID 56952062778160

The HCG Home Use Pregnancy Test Midstream (Colloidal Gold) is a rapid chromatographic immunoassay for thequalitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

• Primary Device ID: 56952062778160
• NIH Device Record Key: 50eff537-ef2a-4544-8c4f-a313167b9ebc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
• Version Model Number: Midstream,5PCS/BOX
• Company DUNS: 546403492
• Company Name: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
• Device Count: 5
• 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06952062778165 [Primary]
GS1	56952062778160 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240242

FDA Product Code

• JHI: Visual, Pregnancy Hcg, Prescription Use

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: 2025-02-20
• Device Publish Date: 2025-02-12