AccessGUDID - DEVICE: Dermatophyte and C. albicans Real Time PCR kit (05713106994627)

GUDID

Device Identifier (DI) Information

Brand Name: Dermatophyte and C. albicans Real Time PCR kit
Version or Model: 99462
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 99462
Company Name: Ssi Diagnostica A/S

Primary DI Number: 05713106994627
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305684449 *Terms of Use

Device Description: Intended use The Dermatophyte and C. albicans Real Time PCR Kit is an in vitro diagnostic kit for the quantitative detection of general dermatophytes (pan-dermatophytes), Trichophyton (T.) rubrum and Candida (C.) albicans in nail, skin, and hair specimens.

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):	Yes
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?
62577	Multiple dermatophyte species 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 dermatophyte species, which may include M. canis, M. audouinii, T. rubrum and T. violaceum in a clinical specimen, using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSR	Kit, Identification, Dermatophyte

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Special Storage Condition, Specify: Stored at a dark place at -20 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e36ef7e7-bad7-4b7c-9c7e-f66430c346e3
Public Version Date: December 05, 2022
Public Version Number: 1
DI Record Publish Date: November 25, 2022