Macro & Micro-Test Fluorescence Immunoassay Analyzer

GUDID 06974849369397

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

Fluorescent immunoassay analyser IVD, laboratory

• Primary Device ID: 06974849369397
• NIH Device Record Key: 0393793a-4e77-4e04-8e17-20e61d17e454
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Macro & Micro-Test Fluorescence Immunoassay Analyzer
• Version Model Number: HWTS-IF2000
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974849369397 [Primary]

FDA Product Code

• KHO: Fluorometer, For Clinical 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: 2024-09-27
• Device Publish Date: 2024-09-19

On-Brand Devices [Macro & Micro-Test Fluorescence Immunoassay Analyzer]

• 06974849369397: HWTS-IF2000
• 06974849369380: HWTS-IF1000