AccessGUDID - DEVICE: N/A (00819398027304)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: Z75
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z75
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398027304
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: PYR Test Kit, 25 tests, with 5ml chromogenic developer, on paper disks A rapid test for Group A Strep and Enterococcus, both of which are PYR positive, all other streps are negative. A more reliable test for Group A Strep than bacitracin, the L-pyrrolidonyl -B-napthylamide impregnated disks serve as a substrate for the detection of pyrrolidonyl peptidase. Contains: PYR Test Disk (25) 00819398027038 Developer Reagent (1) 00819398028585

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?
63421	Pyrrolidonyl arylamidase (PYR) activity IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of pyrrolidonyl arylamidase (PYR) activity in a clinical specimen and/or culture isolate within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test used in the laboratory or in point-of-care analyses typically to differentiate Group A streptococci and enterococci from Group D streptococci. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JTO	Discs, Strips And Reagents, Microorganism Differentiation

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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eb5422f5-ccc1-4e4a-8be5-00d12c67c890
Public Version Date: November 28, 2022
Public Version Number: 2
DI Record Publish Date: August 10, 2020