AccessGUDID - DEVICE: Strep-A-Chek(TM) Strips (100 pcs) (00863251000225)

GUDID

Device Identifier (DI) Information

Brand Name: Strep-A-Chek(TM) Strips (100 pcs)
Version or Model: 13-051-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 13-051-00
Company Name: E-Y Laboratories, Inc.

Primary DI Number: 00863251000225
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 087212858 *Terms of Use

Device Description: Strep-A-Chek™ Reagent Strips are paper 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. The PYR enzyme has been shown to be accurate in differentiating Group A streptococci and enterococci from other Streptococcus species. Strep-A-Chek™ 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. Strep-A-Chek™ Reagent Strips are a component of the Strep-A-Chek™ Kit (Cat. No: 13-050-00) and are to be used with EY-20™ Reagent Tubes. 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.

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: 30533935-bc00-439a-b9ed-eac7c44e4e1e
Public Version Date: September 11, 2023
Public Version Number: 1
DI Record Publish Date: September 01, 2023