DEVICE: T.Cell Xtend® (15051716000022)

Device Identifier (DI) Information

T.Cell Xtend®
TTK.610
In Commercial Distribution
TTK.610US
Oxford Immunotec, Inc.
15051716000022
GS1

1
009744265 *Terms of Use
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).
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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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OJN Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P070006 006
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Handling Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

60c1d520-5387-412e-bb88-35aea82359e0
July 06, 2018
4
August 12, 2014
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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