AccessGUDID - DEVICE: OpsisDx (B550ENT0020)

GUDID

Device Identifier (DI) Information

Brand Name: OpsisDx
Version or Model: Signal Enhancer
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ENT002
Company Name: ENTOPSIS, LLC

Primary DI Number: B550ENT0020
Issuing Agency: HIBCC
Commercial Distribution End Date: January 01, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 078294784 *Terms of Use

Device Description: Additive used in preparing OpsisDx urine fixative and OpsisDx standard media

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):	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?
63832	Multiple-type clinical chemistry analyte profile IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NSU	Instrumentation For Clinical Multiplex Test Systems

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ded2519a-d38e-4f83-b09c-40e62c100949
Public Version Date: April 12, 2024
Public Version Number: 2
DI Record Publish Date: August 26, 2021