Flowflex Plus RSV + Flu A/B + COVID Home Test

Basic Information

• Brand Name: Flowflex Plus RSV + Flu A/B + COVID Home Test
• Primary DI: 00810107290224
• Version / Model: L03A-R1445, L03A-R1545, L03A-R1645, L03A-R1745
• Catalog Number: L03A-R1445, L03A-R1545, L03A-R1645, L03A-R1745
• Company Name: Acon Laboratories, Inc.
• Labeler DUNS: 781100966
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-06
• Public Version: 1
• Public Version Date: 2025-11-14
• Public Version Status: New
• Public Device Record Key: 388c9b91-772c-4c46-8aef-5b5af63295b3

Device Description

1 Test per kit (L03A-R1445):Test Cassette (1), Extraction Buffer Tube (1), Swab Guard (1), Nasal Swab (1); 2 Test per kit (L03A-R1545): Test Cassettes (2), Extraction Buffer Tubes (2), Swab Guards (2), Nasal Swabs (2); 5 Test per kit (L03A-R1645): Test Cassettes (5), Extraction Buffer Tubes (5), Swab Guards (5), Nasal Swabs (5); 25 Test per kit (L03A-R1745): Test Cassettes (25), Extraction Buffer Tubes (25), Swab Guards (25), Nasal Swabs (25)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
SCA	Multi-analyte respiratory virus antigen detection test	Microbiology	866.3987	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66040	Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple virus genera associated with respiratory disease in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30810107290249	GS1	Carton	48	In Commercial Distribution
Package	00810107290248	GS1	Kit Box	2	In Commercial Distribution
Primary	00810107290224	GS1
Package	20810107290235	GS1	Carton	12	In Commercial Distribution
Package	10810107290238	GS1	Inner Pack	12	In Commercial Distribution
Package	00810107290231	GS1	Kit Box	1	In Commercial Distribution
Package	40810107290246	GS1	Tray	18	In Commercial Distribution
Package	30810107290256	GS1	Carton	36	In Commercial Distribution
Package	00810107290255	GS1	Kit Box	5	In Commercial Distribution
Package	20810107290259	GS1	Carton	12	In Commercial Distribution
Package	10810107290252	GS1	Inner Pack	12	In Commercial Distribution
Package	30810107290232	GS1	Carton	48	In Commercial Distribution
Package	20810107290242	GS1	Carton	12	In Commercial Distribution
Package	10810107290245	GS1	Inner Pack	12	In Commercial Distribution
Package	40810107290253	GS1	Tray	10	In Commercial Distribution
Package	30810107290263	GS1	Carton	24	In Commercial Distribution
Package	00810107290262	GS1	Kit Box	25	In Commercial Distribution

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.