AccessGUDID - DEVICE: BioCode MDx 3000 Optical Calibration and Verification Kit (00851034007028)

GUDID

Device Identifier (DI) Information

Brand Name: BioCode MDx 3000 Optical Calibration and Verification Kit
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 64-C0002
Company Name: APPLIED BIOCODE, INC.

Primary DI Number: 00851034007028
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004580003 *Terms of Use

Device Description: Kit containing calibrators and controls for MDx 3000.

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):	No
Over the Counter (OTC):	Yes
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?
61061	Multiple-type gastrointestinal pathogen nucleic acid IVD, calibrator	A material which is used to establish known points of reference for as assay intended to be used for the quantitative and/or qualitative detection of nucleic acid from multiple types of pathogens associated with gastrointestinal disease, in a clinical specimen. Microorganisms detected may include bacteria, viruses, fungi and/or parasites such as, but are not limited to Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Norovirus, Rotavirus, Clostridium difficile, Giardia, Bacillus and/or Vibrio species.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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
Handling Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 173408ab-db29-415f-8001-4ff3bb7a9b14
Public Version Date: December 21, 2020
Public Version Number: 2
DI Record Publish Date: July 30, 2019