AccessGUDID - DEVICE: CarboFerm™ (00816576029068)

GUDID

Device Identifier (DI) Information

Brand Name: CarboFerm™
Version or Model: Z98
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z98
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00816576029068
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 24
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: CarboFerm™ I, rapid carbohydrate test for Neisseria and Moraxella, 24 tests per kit For the rapid identification and differentiation of Neisseria spp., including N. gonorrhoeae and N. meningitidis, and Moraxella (Branhamella) catarrhalis. CarboFerm™ uses acid production from carbohydrates to differentiate and identify Neisseria species and M. catarrhalis. Performs a glucose, lactose, maltose, sucrose, and butyrate test

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?
50423	Multiple Haemophilus/Neisseria bacteria species culture isolate identification IVD, kit	A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of bacteria belonging to the Haemophilus or Neisseria genera, that have been isolated by culture from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LIB	Device, General Purpose, Microbiology, Diagnostic

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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 169a2d37-970e-44c4-906f-24f2e5e48825
Public Version Date: August 20, 2020
Public Version Number: 1
DI Record Publish Date: August 12, 2020