DEVICE: IDS-iSYS System Liquid (Syst. l) (05425030421017)
Device Identifier (DI) Information
IDS-iSYS System Liquid (Syst. l)
IS-CS100
In Commercial Distribution
Immunodiagnostic Systems SA
IS-CS100
In Commercial Distribution
Immunodiagnostic Systems SA
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
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? |
---|---|---|---|---|
59058 | Wash/cleaning solution IVD, automated/semi-automated system |
A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in an upright position in the dark at 15 to 25 degrees celsius |
Storage Environment Temperature: between 15 and 25 Degrees Celsius |
Handling Environment Temperature: between 15 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
c58097e2-723d-4b49-937e-2ee14198a093
March 29, 2018
2
April 01, 2016
March 29, 2018
2
April 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
+32042522636
info.be@idsplc.com
info.be@idsplc.com