AccessGUDID - DEVICE: EY-20(TM) Reagent Tube (00863251000232)

GUDID

Device Identifier (DI) Information

Brand Name: EY-20(TM) Reagent Tube
Version or Model: 13-020-50
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 13-020-50
Company Name: E-Y Laboratories, Inc.

Primary DI Number: 00863251000232
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 087212858 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
51707	Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from Group A beta-haemolytic Streptococcus bacteria in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b5cc6f6d-08b5-46f2-8456-9ce1d6c29fd2
Public Version Date: September 11, 2023
Public Version Number: 1
DI Record Publish Date: September 01, 2023