DEVICE: Sample Preparation System PS-10 (04987562501908)
Device Identifier (DI) Information
Sample Preparation System PS-10
PS-10
In Commercial Distribution
SYSMEX CORPORATION
PS-10
In Commercial Distribution
SYSMEX CORPORATION
The Sample Preparation System PS-10 is a fully automated, user-configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]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? |
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65174 | Pipetting system IVD |
An electrically-powered, software-operated instrument intended to be used in the laboratory to withdraw, transfer, and/or inject volumes of fluid materials, typically from one laboratory container to another, during an in vitro diagnostic procedure. The device is programmable to allow for automated single and/or multichannel fluid handling and delivery of user-specified volumes into a single container or multiple containers (e.g., microplate) simultaneously. It has no other specimen processing capabilities.
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FDA Product Code
[?]Product Code | Product Code Name |
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PER | Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
8df528c8-052f-4a71-818a-f188724f94d3
December 08, 2022
1
November 30, 2022
December 08, 2022
1
November 30, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(888)879-7639
crc@sysmex.com
crc@sysmex.com