DEVICE: CAPILLARYS CDT MAXI KIT (03607360020296)
Device Identifier (DI) Information
CAPILLARYS CDT MAXI KIT
2029
In Commercial Distribution
2029
SEBIA
2029
In Commercial Distribution
2029
SEBIA
CARBOHYDRATE DEF TRANSFERRIN BY CE MAXI KIT
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
65813 | Transferrin/transferrin isoform IVD, kit, electrophoresis |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of transferrin or a transferrin isoform(s) [e.g., beta-2-transferrin, carbohydrate deficient transferrin] in a clinical specimen, using an electrophoresis method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NAO | Test, Carbohydrate Deficient Transferrin |
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 15 and 30 Degrees Celsius |
Special Storage Condition, Specify: DO NOT FREEZE FRAGILE HANDLE WITH CARE KEEP DRY |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
23dbe60c-6295-4869-a8b8-b2b0521e5f52
September 13, 2023
2
December 08, 2022
September 13, 2023
2
December 08, 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 |
---|---|---|---|---|---|
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
[?]
No Customer Contact currently defined