AccessGUDID - DEVICE: Fluoro-CheckTM NT-proBNP (00895160002434)

GUDID

Device Identifier (DI) Information

Brand Name: Fluoro-CheckTM NT-proBNP
Version or Model: TF3152
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TF3152
Company Name: NANO-DITECH CORPORATION

Primary DI Number: 00895160002434
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 126544316 *Terms of Use

Device Description: Fluorescence In Vitro Diagnostic Test kit for the determination of NT-proBNP (N-terminal pro-Brain natriuretic peptide) in human whole blood, serum or plasma

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:	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?
47352	B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of B-type natriuretic protein (BNP) and/or N-terminal pro b-type natriuretic peptide (NT-proBNP) in a clinical specimen, using a fluorescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBC	Test, Natriuretic Peptide

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 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 293b7375-c433-472e-be54-b08a737a6a5f
Public Version Date: June 29, 2023
Public Version Number: 3
DI Record Publish Date: October 05, 2016