Flowflex Plus Strep A Rapid Test Cassette

Basic Information

• Brand Name: Flowflex Plus Strep A Rapid Test Cassette
• Primary DI: 00810107290132
• Version / Model: L03A-R0115
• Catalog Number: L03A-R0115
• Company Name: Acon Laboratories, Inc.
• Labeler DUNS: 781100966
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-01
• Public Version: 2
• Public Version Date: 2026-01-15
• Public Version Status: Update
• Public Device Record Key: cf25e486-2e1f-4f9a-979f-4da23362198f

Device Description

25 Test per kit (L03A-R0115):Test Cassettes (27), Test Tubes (27), Dropper Tips (27), Throat Swabs (27), Reagent A (1), Reagent B (1), Positive Control (1), Negative Control (1)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GTY	ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.	Microbiology	866.3740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51707	Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from Group A beta-haemolytic Streptococcus bacteria in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20810107290143	GS1	Carton	24	In Commercial Distribution
Package	00810107290149	GS1	Kit Box	25	In Commercial Distribution
Primary	00810107290132	GS1

Customer Contacts

• Phone: [phone] ext. 1
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.