Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)

GUDID 06974849369267

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

Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 06974849369267
• NIH Device Record Key: 35d45677-356d-48f0-9468-ec95d130995f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)
• Version Model Number: 50 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: false
• 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	06974849369267 [Primary]

FDA Product Code

• NJR: Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

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 [Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)]

• 06974849369274: 48 tests/kit
• 06974849369267: 50 tests/kit
• 06974849369250: 20 tests/kit