AccessGUDID - DEVICE: NTproBNP Install Kit (00850011135570)

GUDID

Device Identifier (DI) Information

Brand Name: NTproBNP Install Kit
Version or Model: C-1001ro
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Lgc Clinical Diagnostics, Inc.

Primary DI Number: 00850011135570
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 075886031 *Terms of Use

Device Description: Install Kits are unassayed controls intended for use during assay installations for the following analyte: N-Terminal pro hormone Btype Natriuretic Peptide (NTproBNP).

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?
47354	B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control	A material which is used to verify the performance of an assay 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)

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 -25 and -10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1cdaf18e-1b50-48fb-b083-f01a44be602d
Public Version Date: April 27, 2023
Public Version Number: 1
DI Record Publish Date: April 19, 2023