DEVICE: Optilite CH50 Reagent (05051700018210)
Device Identifier (DI) Information
Optilite CH50 Reagent
NK095.OPT.A
In Commercial Distribution
THE BINDING SITE GROUP LIMITED
NK095.OPT.A
In Commercial Distribution
THE BINDING SITE GROUP LIMITED
No description.
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? |
---|---|---|---|---|
53662 | Total complement activity (CH50) IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total complement activity (CH50 ) in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DAE | Complement C9, Antigen, Antiserum, Control |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K150412 | 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
26f7f9aa-3be2-4924-a33c-048f189e9e71
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 |
---|---|---|---|---|---|
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
[?]
+4401214569500
info@bindingsite.co.uk
info@bindingsite.co.uk