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Flowflex Plus COVID-19 and Flu A/B Home Test

FDA UDI

Class N (US FDA UDI)

by ACON Laboratories, Inc.

Identity

Trade Name
Flowflex Plus COVID-19 and Flu A/B Home Test FDA UDI
Generic Name
Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing FDA UDI
Device Name
1 Test per kit (L03A-R0645):Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1); 2 Test per kit (L03A-R0745): Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2); 5 Test per kit (L03A-R0845): Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5); 25 Test per kit (L03A-R0945): Test Cassettes (25), Extraction Buffer Tubes (25), Nasal Swabs (25) FDA UDI
Model / Reference
L03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945 FDA UDI
Description
1 Test per kit (L03A-R0645):Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1); 2 Test per kit (L03A-R0745): Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2); 5 Test per kit (L03A-R0845): Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5); 25 Test per kit (L03A-R0945): Test Cassettes (25), Extraction Buffer Tubes (25), Nasal Swabs (25) FDA UDI

Identifiers

Catalog Number
L03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945 FDA UDI
Primary DI / UDI-DI
00810107290002 FDA UDI
FDA Product Code
QMN FDA UDI
GMDN Term
Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing FDA UDI

Classification

Device Class
N FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing

Flowflex Plus COVID-19 and Flu A/B Home Test by ACON Laboratories, Inc. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ACON Laboratories, Inc.

Sources (1)

  • FDA UDI ea26ffcf-37f6-4a75-a167-d82e64717edd 36 fields · synced Jun 9, 2026