Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold)

GUDID 06974849369182

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

Multiple gastrointestinal virus antigen IVD, kit, rapid ICT, clinical

• Primary Device ID: 06974849369182
• NIH Device Record Key: 80ad15c4-e92a-4b44-a4e4-9a096bd46e9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold)
• Version Model Number: 10 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: 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	06974849369182 [Primary]

FDA Product Code

• GOB: Antigens, Ha (Including Ha Control), Adenovirus 1-33

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: 2022-12-14
• Device Publish Date: 2022-12-06

On-Brand Devices [Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold)]

• 06974849369199: 50 tests/kit
• 06974849369182: 10 tests/kit