AccessGUDID - DEVICE: Alere NT-proBNP for Alinity Control Kit (05055845400527)

GUDID

Device Identifier (DI) Information

Brand Name: Alere NT-proBNP for Alinity Control Kit
Version or Model: 04S7911
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 04S7911
Company Name: AXIS-SHIELD DIAGNOSTICS LIMITED

Primary DI Number: 05055845400527
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 229062427 *Terms of Use

Device Description: The Alere NT-proBNP for Alinity i Controls are for the estimation of test precision and the detection of systematic analytical deviations of the Alinity i analyzer when used for the quantitative determination of N-terminal pro B-type natriuretic peptide (NT-proBNP) in human serum and plasma. For additional information, refer to the Alere NT-proBNP for Alinity i reagent package insert and the Alinity ci-series Operations Manual.

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
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?
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: 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cf12249b-4bd7-466d-b46f-478bead907a7
Public Version Date: March 07, 2025
Public Version Number: 1
DI Record Publish Date: February 27, 2025