DEVICE: NA (05056080500041)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
56108 | Fibrinogen degradation product (FDP) IVD, kit, rapid agglutination, clinical |
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of fibrinogen degradation products (FDP) in a clinical specimen within a short period relative to standard laboratory testing procedures, using a rapid agglutination method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
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
18df1491-a35f-4ea3-a97f-0cdc71ad04a3
November 28, 2022
3
September 24, 2016
November 28, 2022
3
September 24, 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
[?]
+4401322295600
ITechnicalSupport@remel.com
ITechnicalSupport@remel.com