AccessGUDID - DEVICE: N/A (00850041798011)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: KF4012
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Key Scientific Products Incorporated

Primary DI Number: 00850041798011
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 783601115 *Terms of Use

Device Description: he IDENTICULT-AE test is intended for use in the rapid identification of group A streptococci and enterococci from clinical isolates. This kit is also suitable for Gram negative bacilli.Billions of dollars are left on thetable due to missing imagery.The IDENTICULT-AE test is intended for use in the rapid identification of group A streptococci and enterococci from clinical isolates. This kit is also suitable for Gram negative bacilli.

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
No Product Codes

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
Special Storage Condition, Specify: Store between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 888d0237-5b25-4f57-8b51-2d260a6b67c1
Public Version Date: September 18, 2023
Public Version Number: 1
DI Record Publish Date: September 08, 2023