DEVICE: Flowflex Plus COVID-19 and Flu A/B Home Test (00810107290002)

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Device Record History
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Device Identifier (DI) Information
Flowflex Plus COVID-19 and Flu A/B Home Test
L03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945
In Commercial Distribution
L03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945
ACON LABORATORIES, INC.
00810107290002
GS1

1
781100966 *Terms of Use
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)
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
QMN COVID-19 Multi-Analyte Antigen Device
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: 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.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
ea26ffcf-37f6-4a75-a167-d82e64717edd
October 03, 2024
2
August 14, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
30810107290041 24 00810107290040 In Commercial Distribution Carton
00810107290040 25 00810107290002 In Commercial Distribution Kit Box
30810107290034 120 00810107290033 In Commercial Distribution Carton
00810107290033 5 00810107290002 In Commercial Distribution Kit Box
60810107290035 36 00810107290033 In Commercial Distribution Carton
40810107290024 6 00810107290026 In Commercial Distribution Inner Pack
00810107290026 2 00810107290002 In Commercial Distribution Kit Box
10810107290030 12 00810107290033 In Commercial Distribution Inner Pack
50810107290014 8 40810107290017 In Commercial Distribution Carton
40810107290017 6 00810107290019 In Commercial Distribution Inner Pack
00810107290019 1 00810107290002 In Commercial Distribution Kit Box
10810107290016 12 00810107290019 In Commercial Distribution Inner Pack
20810107290020 18 10810107290023 In Commercial Distribution Carton
10810107290023 12 00810107290026 In Commercial Distribution Inner Pack
20810107290037 8 10810107290030 In Commercial Distribution Carton
60810107290028 48 00810107290026 In Commercial Distribution Carton
60810107290011 48 00810107290019 In Commercial Distribution Carton
40810107290031 6 00810107290033 In Commercial Distribution Inner Pack
30810107290010 300 00810107290019 In Commercial Distribution Carton
50810107290038 6 40810107290031 In Commercial Distribution Carton
30810107290027 210 00810107290026 In Commercial Distribution Carton
20810107290013 24 10810107290016 In Commercial Distribution Carton
70810107290032 10 00810107290033 In Commercial Distribution Tray
80810107290039 8 70810107290032 In Commercial Distribution Carton
50810107290021 8 40810107290024 In Commercial Distribution Carton
80810107290015 252 00810107290019 In Commercial Distribution Carton
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)838-9502 1
support@aconlabs.com
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