AccessGUDID - DEVICE: Clostridium difficile (CDF) Nucleic Acid Test Cartridge (00840487101605)

GUDID

Device Identifier (DI) Information

Brand Name: Clostridium difficile (CDF) Nucleic Acid Test Cartridge
Version or Model: 20-006-022
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20-006-022
Company Name: LUMINEX CORPORATION

Primary DI Number: 00840487101605
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080778937 *Terms of Use
Previous DI: 00857573006157

Device Description: The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).

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:	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?
59859	Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with gastrointestinal disease, in a clinical specimen, using a microarray method. 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
OZN	C. Difficile toxin gene amplification assay

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123197	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: c06d338b-0611-49d3-a9e0-e1a3d3a4b33e
Public Version Date: December 21, 2020
Public Version Number: 2
DI Record Publish Date: December 05, 2019