Rubber Panel T.R.U.E. TEST
STN: 125579
Proper Name: Rubber Panel Thin-Layer Rapid Use Epicutaneous Patch Test
Trade Name: Rubber Panel T.R.U.E. TEST®
Manufacturer: SmartPractice Denmark ApS
Indication:
- 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 5 substances included on the Rubber Panel T.R.U.E. TEST
Product Information
- Package Insert - Rubber Panel T.R.U.E. TEST
- Demographic Subgroup Information - Rubber Panel Thin-Layer Rapid Use Epicutaneous Patch Test
Refer to Section 1.1 of the clinical reviewer memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
Supporting Documents
- March 3, 2017 Approval Letter - Rubber Panel T.R.U.E. TEST
- March 2, 2017 Summary Basis for Regulatory Action - Rubber Panel T.R.U.E. TEST
- Clinical Review, May 17, 2016 - RUBBER PANEL T.R.U.E TEST
- Statistical Review - RUBBER PANEL T.R.U.E TEST
- Approval History, Letters, Reviews, Related Documents-RUBBER PANEL T.R.U.E TEST