AccessGUDID - DEVICE: CatScreen™ (00819398028554)

GUDID

Device Identifier (DI) Information

Brand Name: CatScreen™
Version or Model: Z110
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z110
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398028554
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: CatScreen™, rapid test for Moraxella (Branhamella) catarrhalis (M. cat.)using butyrate esterase, 25 disks tests per package Rapid test for the detection of the enzyme butyrate esterase in bacteria isolated on culture media for the presumptive identification of Branhamella (Moraxella) catarrhalis. Performs a butyrate test within 5 minutes. Simply moisten disk, inoculate with organism, then wait for the development of a red color.

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:	No
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?
50420	Multiple aerobic gram positive bacteria species culture isolate identification IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the differentiation and/or identification of one or multiple species of aerobic gram positive bacteria that have been isolated by culture from a clinical specimen. Bacteria which may be identified typically belong to the genera Staphylococcus, Enterococcus, or may represent other gram positive cocci and gram positive bacilli genera.	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 [?]
K960996	000

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
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: d8b019a8-c33f-49a5-8b00-987af34ee78f
Public Version Date: July 17, 2020
Public Version Number: 1
DI Record Publish Date: July 09, 2020