Strep-A-Chek(TM) Kit 13-050-00

GUDID 00863251000201

Strep-A-Chekâ„¢ Kit is intended for use in the detection of pyrrolidonyl arylamidase (PYR) from beta-hemolytic colonies grown on blood agar plates, as an aid in the presumptive identification of Group A Streptococcus. Strep-A-Chekâ„¢ consists of Strep-A-Chekâ„¢ Reagent Strips impregnated with a chromogenic substrate for the detection of pyrrolidonyl arylamidase (PYR), an enzyme reported to be present in Group A beta-hemolytic Streptococcus, and EY-20â„¢ Reagent Tubes which contain a diazo dye color developer, Fast Garnet. The PYR enzyme has been shown to be accurate in differentiating Group A streptococci and enterococci from other Streptococcus species. Strep-A-Chekâ„¢ Kit when used in conjunction with other tests such as CAMP, hippurate, and bile-esculin, may be used for the presumptive identification of beta-hemolytic streptococci or enterococci from any source.

E-Y Laboratories, Inc.

Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Primary Device ID00863251000201
NIH Device Record Key22224e6b-f44c-40db-9945-8933c2e3b1bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameStrep-A-Chek(TM) Kit
Version Model Number13-050-00
Catalog Number13-050-00
Company DUNS087212858
Company NameE-Y Laboratories, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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-Counterfalse

Customer Support Contacts

Phone6503423296
Emailorders@eylabs.com
Phone6503423296
Emailorders@eylabs.com
Phone6503423296
Emailorders@eylabs.com
Phone6503423296
Emailorders@eylabs.com
Phone6503423296
Emailorders@eylabs.com
Phone6503423296
Emailorders@eylabs.com
Phone6503423296
Emailorders@eylabs.com
Phone6503423296
Emailorders@eylabs.com
Phone6503423296
Emailorders@eylabs.com
Phone6503423296
Emailorders@eylabs.com
Phone6503423296
Emailorders@eylabs.com
Phone6503423296
Emailorders@eylabs.com
Phone6503423296
Emailorders@eylabs.com
Phone6503423296
Emailorders@eylabs.com
Phone6503423296
Emailorders@eylabs.com
Phone6503423296
Emailorders@eylabs.com
Phone6503423296
Emailorders@eylabs.com
Phone6503423296
Emailorders@eylabs.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100863251000201 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-11
Device Publish Date2023-09-01

Devices Manufactured by E-Y Laboratories, Inc.

00863251000201 - Strep-A-Chek(TM) Kit2023-09-11Strep-A-Chekâ„¢ Kit is intended for use in the detection of pyrrolidonyl arylamidase (PYR) from beta-hemolytic colonies grown on blood agar plates, as an aid in the presumptive identification of Group A Streptococcus. Strep-A-Chekâ„¢ consists of Strep-A-Chekâ„¢ Reagent Strips impregnated with a chromogenic substrate for the detection of pyrrolidonyl arylamidase (PYR), an enzyme reported to be present in Group A beta-hemolytic Streptococcus, and EY-20â„¢ Reagent Tubes which contain a diazo dye color developer, Fast Garnet. The PYR enzyme has been shown to be accurate in differentiating Group A streptococci and enterococci from other Streptococcus species. Strep-A-Chekâ„¢ Kit when used in conjunction with other tests such as CAMP, hippurate, and bile-esculin, may be used for the presumptive identification of beta-hemolytic streptococci or enterococci from any source.
00863251000201 - Strep-A-Chek(TM) Kit2023-09-11 Strep-A-Chekâ„¢ Kit is intended for use in the detection of pyrrolidonyl arylamidase (PYR) from beta-hemolytic colonies grown on
00863251000218 - Gonochek®-II Reagent Tubes2023-09-11 Gonochek®-II is intended for the use in the detection of prolyliminopeptidase, gammaglutamylaminopeptidase, and beta-galactosid
00863251000225 - Strep-A-Chek(TM) Strips (100 pcs)2023-09-11 Strep-A-Chekâ„¢ Reagent Strips are paper strips impregnated with a chromogenic substrate for the detection of pyrrolidonyl aryla
00863251000232 - EY-20(TM) Reagent Tube2023-09-11 The EY-20â„¢ Reagent Tubes are a component of the Strep-A-Chekâ„¢ kit (Cat. No: 13-050-00) and are to be used with Strep-A-Chekâ
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.