Flowflex Plus Strep A Rapid Test Cassette L03A-R0115

GUDID 20810107290143

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

Acon Laboratories, Inc.

Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Primary Device ID20810107290143
NIH Device Record Keycf25e486-2e1f-4f9a-979f-4da23362198f
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlowflex Plus Strep A Rapid Test Cassette
Version Model NumberL03A-R0115
Catalog NumberL03A-R0115
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 Perscriptiontrue
OTC Over-The-Counterfalse

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

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.

Device Identifiers

Device Issuing AgencyDevice ID
GS100810107290132 [Primary]
GS100810107290149 [Package]
Contains: 00810107290132
Package: Kit Box [25 Units]
In Commercial Distribution
GS120810107290143 [Package]
Contains: 00810107290149
Package: Carton [24 Units]
In Commercial Distribution

FDA Product Code

GTYANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-09
Device Publish Date2025-12-01

Devices Manufactured by Acon Laboratories, Inc.

20810107290143 - Flowflex Plus Strep A Rapid Test Cassette2025-12-0925 Test per kit (L03A-R0115):Test Cassettes (25), Test Tubes (25), Dropper Tips (25), Throat Swabs (25), Reagent A (1), Reagent B (1), Positive Control (1), Negative Control (1)
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