AccessGUDID - DEVICE: T-SPOT®.TB96 (15051716000008)

GUDID

Device Identifier (DI) Information

Brand Name: T-SPOT®.TB96
Version or Model: TB.200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TB.200US
Company Name: Oxford Immunotec, Inc.

Primary DI Number: 15051716000008
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009744265 *Terms of Use

Device Description: For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and indicated for use as an aid in the diagnosis of m.Tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations.

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?
51174	Mycobacterium tuberculosis complex species antigen IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from bacterial species of the Mycobacterium tuberculosis complex (M. tuberculosis, M. bovis, M. bovis Bacillus Calmette-Guerin, M. africanum, M. canetti, M. microti, M. caprae and M. pinnipedi) in a clinical specimen and/or culture isolate, using an enzyme immunoassay (EIA) method.	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	011

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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b0c9196a-3152-47a3-823c-4b221480267f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 15, 2015