DEVICE: Human Antithrombin III BINDARID™ Radial Immunodiffusion Kit (05051700010702)
Device Identifier (DI) Information
Human Antithrombin III BINDARID™ Radial Immunodiffusion Kit
RN040.3
In Commercial Distribution
THE BINDING SITE GROUP LIMITED
RN040.3
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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61983 | Antithrombin III (ATIII) IVD, kit, precipitation/immunodiffusion |
A collection of reagents and other associated materials intended to be used for the quantitative measurement of antithrombin III (ATIII) in a clinical specimen, using a precipitation/immunodiffusion method. ATIII inhibits coagulation and its deficiency is a result of a rare hereditary disorder, which increases the risk of thrombosis.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JBQ | Antithrombin Iii Quantitation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K913667 | 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
3758c469-799f-4cc3-9035-37ae30c1aaa0
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