AccessGUDID - DEVICE: N/A (00819398028134)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: CBT1000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CBT1000
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398028134
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1000
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: Strep B Carrot Broth Tiles 1000 tiles/bag For the selective enrichment and identification of beta-hemolytic group B streptococci (S. agalactiae) from clinical specimens. Tile must be added to broth (not included) upon inoculation.

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?
58684	Differential/selective broth culture medium IVD	A broth culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing in the same medium. It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSI	Culture Media, Selective And Differential

FDA Premarket Submission

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

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: 1a14e7da-ec0c-4587-9f52-15d0991f8922
Public Version Date: June 05, 2020
Public Version Number: 1
DI Record Publish Date: May 28, 2020