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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device herpes virus (vzv, hsv1, hsv2), dna detection assay for cutaneous and mucocutaneous lesion samples
Regulation Description Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel.
Definition For the qualitative detection and differentiation of VZV, HSV1, HSV2- DNA in cutaneous and mucocutaneous lesion samples from symptomatic patients. The assay is not intended for use with cerebral spinal fluid.
Product CodePGI
Regulation Number 866.3309
Device Class 2


Premarket Reviews
ManufacturerDecision
DIASORIN MOLECULAR LLC
  SUBSTANTIALLY EQUIVALENT 2
ELITECHGROUP
  SUBSTANTIALLY EQUIVALENT 1
QUIDEL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 DiaSorin Molecular LLC II Jul-10-2020
2 Luminex Corporation II Aug-15-2019
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