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De Novo DEN140004
- Device
- QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
- Contact
- ronald h lollar
- De Novo number
- DEN140004
- Product code
- PGI
- Regulation
- 866.3309
- Classification name
- herpes virus (vzv, hsv1, hsv2), dna detection assay for cutaneous and mucocutaneous lesion samples
- Decision
- granted (DENG)
- Decision date
- 2014-05-13
- Date received
- 2014-02-21
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- PGI
- Device name
- Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3309
- Implant
- N
- Life sustain/support
- N