AccessGUDID - DEVICE: Simplexa™ C. auris Positive Control Pack (20816101027211)

GUDID

Device Identifier (DI) Information

Brand Name: Simplexa™ C. auris Positive Control Pack
Version or Model: MOL3960
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MOL3960
Company Name: DIASORIN MOLECULAR LLC

Primary DI Number: 20816101027211
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080271715 *Terms of Use

Device Description: No description.

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:	No
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?
65248	Candida auris 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 the yeast Candida auris in a clinical specimen, using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
SBT	Device To Detect Microbial Colonization Directly From Clinical Specimens.

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN230092	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 -30 and -10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a9a10e39-0190-45f4-83be-5c136144b34c
Public Version Date: August 23, 2024
Public Version Number: 2
DI Record Publish Date: July 19, 2024