Fluoro-Check TM Strep A Test

Basic Information

• Brand Name: Fluoro-Check TM Strep A Test
• Primary DI: 00895160002700
• Version / Model: TF8149
• Company Name: NANO-DITECH CORPORATION
• Labeler DUNS: 126544316
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2022-03-15
• Public Version: 1
• Public Version Date: 2022-03-23
• Public Version Status: New
• Public Device Record Key: c6deacc3-1514-4639-93e9-370c7241b591

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
63770	Beta-haemolytic Group A Streptococcus antigen IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Group A beta-haemolytic Streptococcus bacteria in a clinical specimen, using a fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10895160002707	GS1
Primary	00895160002700	GS1