DEVICE: Microsed-System® Automated ESR Analyzer (03661540300035)

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Device Record History
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Device Identifier (DI) Information
Microsed-System® Automated ESR Analyzer
PRD-MSS-EL-08TKNE
In Commercial Distribution
PRD-MSS-EL-08TKNE
ELITECHGROUP INC.
03661540300035
GS1

1
052423787 *Terms of Use
The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative determination of erythrocyte sedimentation rate (ESR) in human whole blood samples by laboratory professionals. Elevated ESR results indicate degrees of inflammation or disease present in the human body.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
56691 Erthrocyte sedimentation rate (ESR) analyser IVD
An electrically-powered automated or semi-automated laboratory instrument intended to be used to determine the erythrocyte sedimentation rate (ESR) of red blood cells in an anticoagulated whole blood specimen.
Active false
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FDA Product Code

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Product Code Product Code Name
GKB Device, Automated Sedimentation Rate
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
2e57dda3-b80a-4fd9-b7c8-c27cffc54cc3
October 09, 2023
1
October 01, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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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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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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(800) 453 2725
service.ebs@elitechgroup.com
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