Macro & Micro-Test LH Test

GUDID 06974849369373

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

Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing

• Primary Device ID: 06974849369373
• NIH Device Record Key: 4778ffd5-846b-4bfe-b0f2-8e1d5869ee04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Macro & Micro-Test LH Test
• Version Model Number: 20 tests/kit
• Company DUNS: 560300737
• Company Name: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	06974849369373 [Primary]

FDA Product Code

• NGE: Test, Luteinizing Hormone (Lh), 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 LH Test]

• 06974849369373: 20 tests/kit
• 06974849369366: 5 tests/kit
• 06974849369359: 3 tests/kit
• 06974849369342: 1 test/kit