AccessGUDID - DEVICE: Germ Tube Cryo™ (00819398026604)

GUDID

Device Identifier (DI) Information

Brand Name: Germ Tube Cryo™
Version or Model: Z217
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z217
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398026604
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: Germ Tube Cryo™, for Candida albicans, 0.5ml, ready to use, 20 vials per package A ready-to-use germ tube solution made up of stabilized animal serum, comes pre-measured in vials. No mixing, measuring, or aliquoting is required! Eliminates exposure to human serum. 0.5ml in each vial. Germ tubes develop on C. albicans within one hour. Serum formula is enhanced for more rapid and luxuriant production of germ tubes.

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):	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?
62108	Candida albicans microbial identification reagent IVD	A substance or reactant containing serum, intended to be used in microbial testing to perform a germ tube test for the identification of Candida albicans isolated by culture from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JTO	Discs, Strips And Reagents, Microorganism Differentiation

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
Storage Environment Temperature: between -20 and -2 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 45e705fc-c07d-458e-94e8-c84cdd2ca3a6
Public Version Date: August 28, 2020
Public Version Number: 1
DI Record Publish Date: August 20, 2020