Flowflex Plus Strep A Rapid Test Strip L03A-R0125, L03A-R0135

GUDID 00810107290187

25 Test per kit (L03A-R0125):Test Strips in pouch (25), Test Tubes (25), Throat Swabs (25), Reagent A (1), Reagent B (1), Positive Control (1), Negative Control (1); 25 Test per kit (L03A-R0135): Test Strips in canister (25), Test Tubes (25), Throat Swabs (25), Reagent A (1), Reagent B (1), Positive Control (1), Negative Control (2)

Acon Laboratories, Inc.

Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Primary Device ID00810107290187
NIH Device Record Key27ffc5e2-a296-4cbd-859c-29481e3a4556
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlowflex Plus Strep A Rapid Test Strip
Version Model NumberL03A-R0125, L03A-R0135
Catalog NumberL03A-R0125, L03A-R0135
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 Datetrue
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
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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. 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 or canister. Do not freeze.

Device Identifiers

Device Issuing AgencyDevice ID
GS100810107290156 [Primary]
GS100810107290170 [Package]
Contains: 00810107290156
Package: Kit Box [25 Units]
In Commercial Distribution
GS100810107290187 [Package]
Contains: 00810107290156
Package: Kit Box [25 Units]
In Commercial Distribution
GS120810107290174 [Package]
Contains: 00810107290170
Package: Carton [24 Units]
In Commercial Distribution
GS120810107290181 [Package]
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

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