EY-20(TM) Reagent Tube 13-020-50

GUDID 00863251000232

The EY-20™ Reagent Tubes are a component of the Strep-A-Chek™ kit (Cat. No: 13-050-00) and are to be used with Strep-A-Chek™ Reagent Strips. They are 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. EY-20™ Reagent Tubes contain a color developer, which when used with the Strep-A-Chek™ Reagent Strips detect pyrrolidonyl arylamidase (PYR), an enzyme present in Group A beta-hemolytic Streptococcus. The PYR enzyme has been shown to be accurate in differentiating Group A streptococci and enterococci from other Streptococcus species. The Strep-A-Chek™ test system, when used in conjunction with other tests such as CAMP, hippurate, and bile-esculin, may be used for the presumptive identification of streptococci or enterococci from any source.

E-Y Laboratories, Inc.

Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

Primary Device ID	00863251000232
NIH Device Record Key	b5cc6f6d-08b5-46f2-8456-9ce1d6c29fd2
Commercial Distribution Status	In Commercial Distribution
Brand Name	EY-20(TM) Reagent Tube
Version Model Number	13-020-50
Catalog Number	13-020-50
Company DUNS	087212858
Company Name	E-Y Laboratories, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	6503423296
Email	orders@eylabs.com
Phone	6503423296
Email	orders@eylabs.com
Phone	6503423296
Email	orders@eylabs.com
Phone	6503423296
Email	orders@eylabs.com
Phone	6503423296
Email	orders@eylabs.com
Phone	6503423296
Email	orders@eylabs.com
Phone	6503423296
Email	orders@eylabs.com
Phone	6503423296
Email	orders@eylabs.com
Phone	6503423296
Email	orders@eylabs.com
Phone	6503423296
Email	orders@eylabs.com
Phone	6503423296
Email	orders@eylabs.com
Phone	6503423296
Email	orders@eylabs.com
Phone	6503423296
Email	orders@eylabs.com
Phone	6503423296
Email	orders@eylabs.com
Phone	6503423296
Email	orders@eylabs.com
Phone	6503423296
Email	orders@eylabs.com
Phone	6503423296
Email	orders@eylabs.com
Phone	6503423296
Email	orders@eylabs.com

Operating and Storage Conditions

Storage Environment Temperature	Between 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863251000232 [Primary]

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-09-11
Device Publish Date	2023-09-01

Devices Manufactured by E-Y Laboratories, Inc.

00863251000201 - Strep-A-Chek(TM) Kit	2023-09-11 Strep-A-Chek™ Kit is intended for use in the detection of pyrrolidonyl arylamidase (PYR) from beta-hemolytic colonies grown on
00863251000218 - Gonochek®-II Reagent Tubes	2023-09-11 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-Chek™ Reagent Strips are paper strips impregnated with a chromogenic substrate for the detection of pyrrolidonyl aryla
00863251000232 - EY-20(TM) Reagent Tube	2023-09-11The EY-20™ Reagent Tubes are a component of the Strep-A-Chek™ kit (Cat. No: 13-050-00) and are to be used with Strep-A-Chek™ Reagent Strips. They are 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. EY-20™ Reagent Tubes contain a color developer, which when used with the Strep-A-Chek™ Reagent Strips detect pyrrolidonyl arylamidase (PYR), an enzyme present in Group A beta-hemolytic Streptococcus. The PYR enzyme has been shown to be accurate in differentiating Group A streptococci and enterococci from other Streptococcus species. The Strep-A-Chek™ test system, when used in conjunction with other tests such as CAMP, hippurate, and bile-esculin, may be used for the presumptive identification of streptococci or enterococci from any source.
00863251000232 - EY-20(TM) Reagent Tube	2023-09-11 The EY-20™ Reagent Tubes are a component of the Strep-A-Chek™ kit (Cat. No: 13-050-00) and are to be used with Strep-A-Chek�