DEVICE: NEPHROCHECK Calibration Verification (Cal Vers) Kit (B0745000090)

Device Identifier (DI) Information

NEPHROCHECK Calibration Verification (Cal Vers) Kit
500009
In Commercial Distribution
500009
ASTUTE MEDICAL, INC.
B0745000090
HIBCC

1
942854212 *Terms of Use
The NEPHROCHECK Calibration Verification (Cal Vers) Materials are to verify calibration of the NEPHROCHECK Test System.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Multiple acute kidney injury (AKI) marker IVD, calibrator A material which is used to establish known points of reference for an assay 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. 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 acid–binding protein (L-FABP).
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FDA Product Code

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Product Code Product Code Name
PIG Acute Kidney Injury Test System
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FDA Premarket Submission

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Premarket Submission Number Not Available/Not Released
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Sterilization

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Storage and Handling

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Storage and Handling
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Clinically Relevant Size

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Size Type Text
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Device Record Status

83bacfbf-2f91-475e-9dbc-f57df5fc8042
March 29, 2018
2
August 12, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Issuing Agency [?] Secondary DI Number
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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