Macro & Micro-Test HCG Pregnancy Test Midstream

GUDID 06974849369304

Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing

• Primary Device ID: 06974849369304
• NIH Device Record Key: c634c837-3ce7-422e-b912-d01141c4e10c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Macro & Micro-Test HCG Pregnancy Test Midstream
• Version Model Number: 1 test/kit
• Company DUNS: 560300737
• Company Name: Jiangsu Macro & Micro-Test Med-Tech 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: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974849369304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230741

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: 2023-12-05
• Device Publish Date: 2023-11-27

On-Brand Devices [Macro & Micro-Test HCG Pregnancy Test Midstream]

• 06974849369335: 5 tests/kit
• 06974849369328: 3 tests/kit
• 06974849369311: 20 tests/kit
• 06974849369304: 1 test/kit