DEVICE: UF-CELLSHEATH (04987562433926)
Device Identifier (DI) Information
UF-CELLSHEATH
BY074501
In Commercial Distribution
SYSMEX CORPORATION
BY074501
In Commercial Distribution
SYSMEX CORPORATION
UF-CELLSHEATH is a sheath fluid for Sysmex Fully Automated Urine Particle Analyzers. This reagent is used in combination with other reagents to obtain a count of the target substance by means of the flow cytometry method.
UF-CELLSHEATH is used as a system fluid for sample aspiration and as a washing fluid with Sysmex Fully Automated Urine Particle Digital Imaging Devices.
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? |
---|---|---|---|---|
58237 | Buffered sample diluent IVD |
A buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood).
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FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GIF | Diluent, Blood Cell |
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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Storage Environment Temperature: between 2 and 35 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 20 Liter |
Device Record Status
c1c11d5a-8c2d-4921-b300-10646b212de0
June 02, 2023
2
November 30, 2022
June 02, 2023
2
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
[?]
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)879-7644
crc@sysmex.com
crc@sysmex.com