AccessGUDID - DEVICE: VIDAS® NEPHROCHECK® (03573026616038)

GUDID

Device Identifier (DI) Information

Brand Name: VIDAS® NEPHROCHECK®
Version or Model: 421172-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMERIEUX SA

Primary DI Number: 03573026616038
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 276816717 *Terms of Use

Device Description: VIDAS NEPHROCHECK 60 TESTS is an automated quantitative test to be used on VIDAS3. It is intended to be used as an aid in the risk assessment for moderate or severe acute kidney injury

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):	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?
60639	Multiple acute kidney injury (AKI) marker IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple antigens or markers associated with acute kidney injury (AKI) in a clinical specimen, using a fluorescent immunoassay method. The range of analytes detected may include (but is not limited to) insulin-like growth factor-binding protein 7 (IGFBP-7), neutrophil gelatinase-associated lipocalin (NGAL), tissue-inhibitor of metalloproteinase-2 (TIMP-2), cystatin C, kidney injury molecule-1 (Kim-1) and/or L-type fatty acidÃ¢â‚¬â€œbinding protein (L-FABP).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PIG	Acute kidney injury test system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210793	000

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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8cdf19ab-9e83-49ca-8e26-cd69f9ae799c
Public Version Date: March 21, 2023
Public Version Number: 1
DI Record Publish Date: March 13, 2023