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