NEPHROCHECK Test Kit 500011

GUDID B0745000110

The Astute Medical NEPHROCHECK Test System is intended to be used in conjunction with clinical evaluation in patients who currently have or have had w

ASTUTE MEDICAL, INC.

Multiple acute kidney injury (AKI) marker IVD, kit, fluorescent immunoassay
Primary Device IDB0745000110
NIH Device Record Keycb10307f-d024-484c-b1bb-76d22049461f
Commercial Distribution StatusIn Commercial Distribution
Brand NameNEPHROCHECK Test Kit
Version Model Number500011
Catalog Number500011
Company DUNS942854212
Company NameASTUTE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB0745000110 [Primary]

FDA Product Code

PIGAcute Kidney Injury Test System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-12

Devices Manufactured by ASTUTE MEDICAL, INC.

B0744000160 - ASTUTE140 Electronic Quality Control (EQC) Device2018-03-29
B0745000090 - NEPHROCHECK Calibration Verification (Cal Vers) Ki2018-03-29 The NEPHROCHECK Calibration Verification (Cal Vers) Materials are to verify calibration of the NEPHROCHECK Test System.
B0745000110 - NEPHROCHECK Test Kit 2018-03-29The Astute Medical NEPHROCHECK Test System is intended to be used in conjunction with clinical evaluation in patients who currently have or have had w
B0745000110 - NEPHROCHECK Test Kit 2018-03-29 The Astute Medical NEPHROCHECK Test System is intended to be used in conjunction with clinical evaluation in patients who curren
B0745000130 - NEPHROCHECK Liquid Control Kit2018-03-29 The NEPHROCHECK Liquid Controls are used for the quality control monitoring of the NEPHROCHECK Test System.
B0745000170 - ASTUTE140 Meter Kit2018-03-29

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