AccessGUDID - DEVICE: EasyScreen™ Gastrointestinal Parasite Detection Kit (09351179001161)

GUDID

Device Identifier (DI) Information

Brand Name: EasyScreen™ Gastrointestinal Parasite Detection Kit
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EP005-HT
Company Name: GENETIC SIGNATURES LIMITED

Primary DI Number: 09351179001161
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 741249601 *Terms of Use

Device Description: The EasyScreen™ Gastrointestinal Parasite Detection Kit is intended for use as an aid in the diagnosis of gastrointestinal illness by qualitative detection of Gastrointestinal Parasites from stool of patients with diarrhoea.

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):	Yes
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?
64636	Multiple faecal parasite nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple faecal parasites (e.g., Giardia, Entamoeba, Cryptosporidium, Dientamoeba species) in a clinical specimen, using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232672	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 -25 and -15 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 765c6820-4711-413d-bb34-8f7f9180b620
Public Version Date: June 26, 2024
Public Version Number: 1
DI Record Publish Date: June 18, 2024