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In this section: Allergenics

T.R.U.E. TEST

STN: 103738
Proper Name:Thin-Layer Rapid Use Epicutaneous Patch Test
Tradename: T.R.U.E. TEST
Manufacturer: Mekos Laboratories AS
Indication:

Indicated for use as an aid in the diagnosis of allergic contact dermatitis in persons 6 years of age and older whose history suggests sensitivity to one or more of the 35 allergens and allergen mixes included on the T.R.U.E. TEST panels.

Product Information

Package Insert - T.R.U.E. TEST

Supporting Documents

Statistical Review - T.R.U.E. Test
Clinical Review - T.R.U.E. TEST
August 25, 2017 Approval Letter - T.R.U.E. TEST
To use as an aid in the diagnosis of allergic contact dermatitis in persons 6 years of age and older whose history suggests sensitivity to one or more of the 35 substances included on the T.R.U.E. TEST panels.
August 25, 2017 Summary Basis for Regulatory Action - T.R.U.E. Test
Supporting Documents older than three years - T.R.U.E. TEST

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