AccessGUDID - DEVICE: EasyScreen™ Gastrointestinal Parasite PCR Positive Control (09351179004070)

GUDID

Device Identifier (DI) Information

Brand Name: EasyScreen™ Gastrointestinal Parasite PCR Positive Control
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PC-PROT-001
Company Name: GENETIC SIGNATURES LIMITED

Primary DI Number: 09351179004070
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 PCR Positive Control (PC-PROT-001) is a control material for nucleic acid testing of patient clinical samples. It is designed to provide a positive PCR signal for each of the protozoan targets in the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005). The Positive Control does not require processing and is designed to be added directly to the PCR mastermix when a positive signal in all detection channels is required for quality control purposes. This Positive Control demonstrates that all PCR targets are being detected as expected, and does not provide any results from clinical specimens. This Positive Control is for Investigational in vitro Diagnostic (IVD) Use Only in hospital and pathology laboratories or similar, by trained personnel.

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?
61060	Multiple-type gastrointestinal pathogen nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative and/or qualitative detection of nucleic acid from multiple types of microorganisms associated with gastrointestinal disease, in a clinical specimen. Microorganisms detected may include bacteria, viruses, fungi and/or parasites such as, but are not limited to Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Norovirus, Rotavirus, Clostridium difficile, Giardia, Bacillus and/or Vibrio species.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
OOI	Real Time Nucleic Acid Amplification System

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: 089bf7d6-34d6-4646-9535-2619499bd5bb
Public Version Date: June 26, 2024
Public Version Number: 1
DI Record Publish Date: June 18, 2024