Proper Name:Thin-Layer Rapid Use Epicutaneous Patch Test
Tradename: T.R.U.E. TEST
Manufacturer: Mekos Laboratories AS
- Indicated for use as an aid in the diagnosis of allergic contact dermatitis in persons 18 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.
November 12, 2015 Summary Basis for Regulatory Action - T.R.U.E. Test(PDF - 52KB) November 12, 2015 Approval Letter - T.R.U.E. TEST(PDF - 29KB)
To replace the excipient for Ethylenediamine Dihydrochloride, from methylcellulose to polyvinylpyrrolidone (PVP or povidone).
October 17, 2014 Summary Basis for Regulatory Action - T.R.U.E. TEST(PDF - 91KB) October 16, 2014 Approval Letter - T.R.U.E. TEST
To include changes in excipient and dose strengths for Neomycin sulfate, Potassium dichromate and Fragrance mix and a change in declared labeled dose for Thiuram mix.
Correction - February 29, 2012 Approval Letter - T.R.U.E. Test[ARCHIVED]
June 15, 2012
February 29, 2012 Approval Letter - T.R.U.E. TEST[ARCHIVED]
Use as an aid in the diagnosis of allergic contact dermatitis in persons 18 years of age and older.
- February 13, 2012 Summary Basis of Regulatory Action - T.R.U.E. Test (PDF - 493KB)
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