Fluoro-Check TM Strep A Test

GUDID 10895160002707

Time resolved fluorescence immunoassay for the qualitative detection of Strep A specific carbohydrate antigen from throat swabs specimen to aid in the diagnosis of Group A Streptococcal infection.

NANO-DITECH CORPORATION

Beta-haemolytic Group A Streptococcus antigen IVD, kit, fluorescent immunoassay

• Primary Device ID: 10895160002707
• NIH Device Record Key: c6deacc3-1514-4639-93e9-370c7241b591
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fluoro-Check TM Strep A Test
• Version Model Number: TF8149
• Company DUNS: 126544316
• Company Name: NANO-DITECH CORPORATION
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00895160002700 [Primary]
GS1	10895160002707 [Unit of 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: 2022-03-23
• Device Publish Date: 2022-03-15

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