Flowflex Plus COVID-19 and Flu A/B Home Test L03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945

GUDID 30810107290041

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)

ACON LABORATORIES, INC.

Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing
Primary Device ID30810107290041
NIH Device Record Keyea26ffcf-37f6-4a75-a167-d82e64717edd
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlowflex Plus COVID-19 and Flu A/B Home Test
Version Model NumberL03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945
Catalog NumberL03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945
Company DUNS781100966
Company NameACON LABORATORIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.
Special Storage Condition, SpecifyBetween 0 and 0 *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.

Device Identifiers

Device Issuing AgencyDevice ID
GS100810107290002 [Primary]
GS100810107290019 [Package]
Contains: 00810107290002
Package: Kit Box [1 Units]
In Commercial Distribution
GS100810107290026 [Package]
Contains: 00810107290002
Package: Kit Box [2 Units]
In Commercial Distribution
GS100810107290033 [Package]
Contains: 00810107290002
Package: Kit Box [5 Units]
In Commercial Distribution
GS100810107290040 [Package]
Contains: 00810107290002
Package: Kit Box [25 Units]
In Commercial Distribution
GS110810107290016 [Package]
Contains: 00810107290019
Package: Inner Pack [12 Units]
In Commercial Distribution
GS110810107290023 [Package]
Contains: 00810107290026
Package: Inner Pack [12 Units]
In Commercial Distribution
GS110810107290030 [Package]
Contains: 00810107290033
Package: Inner Pack [12 Units]
In Commercial Distribution
GS120810107290013 [Package]
Contains: 10810107290016
Package: Carton [24 Units]
In Commercial Distribution
GS120810107290020 [Package]
Contains: 10810107290023
Package: Carton [18 Units]
In Commercial Distribution
GS120810107290037 [Package]
Contains: 10810107290030
Package: Carton [8 Units]
In Commercial Distribution
GS130810107290010 [Package]
Contains: 00810107290019
Package: Carton [300 Units]
In Commercial Distribution
GS130810107290027 [Package]
Contains: 00810107290026
Package: Carton [210 Units]
In Commercial Distribution
GS130810107290034 [Package]
Contains: 00810107290033
Package: Carton [120 Units]
In Commercial Distribution
GS130810107290041 [Package]
Contains: 00810107290040
Package: Carton [24 Units]
In Commercial Distribution
GS140810107290017 [Package]
Contains: 00810107290019
Package: Inner Pack [6 Units]
In Commercial Distribution
GS140810107290024 [Package]
Contains: 00810107290026
Package: Inner Pack [6 Units]
In Commercial Distribution
GS140810107290031 [Package]
Contains: 00810107290033
Package: Inner Pack [6 Units]
In Commercial Distribution
GS150810107290014 [Package]
Contains: 40810107290017
Package: Carton [8 Units]
In Commercial Distribution
GS150810107290021 [Package]
Contains: 40810107290024
Package: Carton [8 Units]
In Commercial Distribution
GS150810107290038 [Package]
Contains: 40810107290031
Package: Carton [6 Units]
In Commercial Distribution
GS160810107290011 [Package]
Contains: 00810107290019
Package: Carton [48 Units]
In Commercial Distribution
GS160810107290028 [Package]
Contains: 00810107290026
Package: Carton [48 Units]
In Commercial Distribution
GS160810107290035 [Package]
Contains: 00810107290033
Package: Carton [36 Units]
In Commercial Distribution
GS170810107290032 [Package]
Contains: 00810107290033
Package: Tray [10 Units]
In Commercial Distribution
GS180810107290015 [Package]
Contains: 00810107290019
Package: Carton [252 Units]
In Commercial Distribution
GS180810107290039 [Package]
Contains: 70810107290032
Package: Carton [8 Units]
In Commercial Distribution

FDA Product Code

QMNCOVID-19 Multi-Analyte Antigen Device

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-22
Device Publish Date2024-08-14

Devices Manufactured by ACON LABORATORIES, INC.

30810107290041 - Flowflex Plus COVID-19 and Flu A/B Home Test2024-08-221 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)
30810107290041 - Flowflex Plus COVID-19 and Flu A/B Home Test2024-08-22 1 Test per kit (L03A-R0645):Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1); 2 Test per kit (L03A-R0745): Test Cas
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20682607630558 - HealthyMe Early Detection Pregnancy Test2024-04-04 Early Detection Pregnancy Test
20682607651256 - HealthyMe UTI Urinary Tract Infection Test Strips2024-04-04 Urinary Tract Infection home test with handle
20682607200508 - MISSION U500 URINE ANALYZER2024-03-18 URINE ANALYZER
20682607200515 - MISSION U500 URINE ANALYZER2024-03-18 URINE ANALYZER with Barcode Reader
20682607660272 - Flowflex COVID-19 Antigen Home Test2021-11-30 Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2)
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