AccessGUDID - DEVICE: T-Cell Select® (05051716000186)

GUDID

Device Identifier (DI) Information

Brand Name: T-Cell Select®
Version or Model: TSK.910
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TSK.910US
Company Name: Oxford Immunotec, Inc.

Primary DI Number: 05051716000186
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009744265 *Terms of Use

Device Description: The T-SPOT.TB test has been evaluated for the processing of blood samples within 8 hours of venipuncture. With the T-Cell Select reagent kit, blood samples stored or maintained at room temperature (18 – 25 °C) for up to 54 (0 – 54) hours post venipuncture can be used with the T-SPOT.TB test. The T-Cell Select reagent may also enable automation of the cell isolation process and reduce sample separation time relative to preparation via the density gradient separation methodology. With the T-Cell Select reagent kit, blood samples may be shipped and/or stored overnight at room temperature (18 – 25 °C), up to 54 (0 – 54) hours post venipuncture.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
56610	T lymphocyte magnetic separation reagent IVD	A substance or reactant intended to be used on clinical specimens for the isolation of T-lymphocytes from a white cell preparation using magnetic beads to achieve component separation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OJN	Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P070006	015

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fecc2d1c-c4bc-4942-af2e-da8de5ae5be7
Public Version Date: February 15, 2023
Public Version Number: 1
DI Record Publish Date: February 07, 2023