Group A Streptococcus Antigen Detection Kit (Immunochromatography)

GUDID 06974849369151

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

Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

• Primary Device ID: 06974849369151
• NIH Device Record Key: 744412ff-e467-4b37-acbf-adaded745a44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Group A Streptococcus Antigen Detection Kit (Immunochromatography)
• 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: 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	06974849369151 [Primary]

FDA Product Code

• GTY: Antigens, All Groups, Streptococcus Spp.

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 [Group A Streptococcus Antigen Detection Kit (Immunochromatography)]

• 06974849369151: 20 tests/kit
• 06974849369144: 1 test/kit