Vaccines, Blood & Biologics
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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 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.
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Supporting Documents
Correction - February 29, 2012 Approval Letter - T.R.U.E. Test
June 15, 2012February 29, 2012 Approval Letter - T.R.U.E. TEST
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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Related Information
FDA Online Label Repository
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