DEVICE: FIDIS (03760170782003)
Device Identifier (DI) Information
FIDIS
Connective 10
In Commercial Distribution
MX 506
THERADIAG SA
Connective 10
In Commercial Distribution
MX 506
THERADIAG SA
Simultaneous detection kit of 10 antibodies: dsDNA, SSA 60, TRIM 21 (SSA 52), SSB, Sm, SmRNP, Scl70, Jo1, CENP-B, ribosomes
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
54824 | Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, multiplex |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for multiple types of antibodies to extractable nuclear antigens (anti-ENA) in a clinical specimen, using a multiplex method.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
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No Product Codes |
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 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b671180f-0028-436c-a0a7-dbc9cd3dbedb
March 08, 2022
3
December 01, 2016
March 08, 2022
3
December 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 |
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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
[?]
0164621012
support@theradiag.com
support@theradiag.com