DEVICE: T.Cell Xtend® (15051716000022)
Device Identifier (DI) Information
T.Cell Xtend®
TTK.610
In Commercial Distribution
TTK.610US
Oxford Immunotec, Inc.
TTK.610
In Commercial Distribution
TTK.610US
Oxford Immunotec, Inc.
Approval for the use of t-cell xtend reagent with the t-spot. Tb test, in order to extend the time from sample collection to sample processing from within 8 hours of venepuncture to between 23 and 30 hours post venepuncture; and to make a technical correction to the t-spot. Tb test package insert to change the number of blood collection tubes required from (2) 6 ml heparin tubes to (1) 6 ml heparin tube. The t-cell xtend reagent is indicated for use with the t-spot. Tb test for the pre-treatment of whole blood prior to lymphocyte separation. The reagent aids in the removal of selected white blood cells from whole blood stored at room temperature (18-25 degrees c).
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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41427 | Cell centrifugation/density gradient separation reagent IVD |
A substance or reactant intended to be used for the isolation of cells from a clinical specimen (e.g., lymphocytes from whole blood, cells from a liquid-based cytology specimen) using centrifugation and density gradient to achieve specimen component separation.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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OJN | Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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P070006 | 006 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
60c1d520-5387-412e-bb88-35aea82359e0
July 06, 2018
4
August 12, 2014
July 06, 2018
4
August 12, 2014
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
[?]
No Customer Contact currently defined