DEVICE: Human Complement C5 BINDARID™ Radial Immunodiffusion Kit (05051700010603)
Device Identifier (DI) Information
Human Complement C5 BINDARID™ Radial Immunodiffusion Kit
RN027.3
In Commercial Distribution
THE BINDING SITE GROUP LIMITED
RN027.3
In Commercial Distribution
THE BINDING SITE GROUP LIMITED
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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61987 | Complement component C5 IVD, kit, precipitation/immunodiffusion |
A collection of reagents and other associated materials intended to be used for the quantitative measurement of complement cascade component C5 in a clinical specimen, using a precipitation/immunodiffusion method. It is useful in the investigation of conditions associated with C5 deficiency such as lupus erythematosus and recurrent Neiserria infections.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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DAY | Complement C5, Antigen, Antiserum, Control |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K942326 | 000 |
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
3ad511cc-c700-4db7-b157-06875b7bfc51
July 06, 2018
3
September 24, 2016
July 06, 2018
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 |
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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
[?]
+441214569500
info@bindingsite.co.uk
info@bindingsite.co.uk